Trial Outcomes & Findings for RewinD-LB - Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies (NCT NCT05869669)

Last Updated: 2026-09-03

Results Overview

Evaluate the efficacy of neflamapimod, compared to placebo, as a treatment for DLB, as assessed by the CDR-SB scale. CDR-SB scores range from 0 to 18 with a higher score indicating worsening of cognitive impairment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

159 participants

Primary outcome timeframe

16 weeks

Results posted on

2026-09-03

Participant Flow

From July 2023 to June 2024, 335 participants were recruited for screening, of which 159 were randomized at 40 centers in the United States, United Kingdom, and Netherlands.

No pre-assignment details to note

Participant milestones

Participant milestones
Measure	Neflamapimod Arm of trial including the 79 participants that were randomly assigned (1:1) to take neflamapimod (active study drug) for 16 weeks during the blinded period.	Placebo Arm of trial including the 80 participants that were randomly assigned (1:1) to take placebo for 16 weeks during the blinded period.	Neflamapimod Only Extension Arm of trial including the 149 participants that continued to the extension phase where all participants received neflamapimod (active study drug) for 32 weeks, either with DP Batch A capsules and/or DP Batch B capsules
Blinded (randomized) Period STARTED	79	80	0
Blinded (randomized) Period COMPLETED	75	77	0
Blinded (randomized) Period NOT COMPLETED	4	3	0
Extension Phase STARTED	0	0	149
Extension Phase Participants who received DP Batch A >50% of the weeks, at Week 16 in the extension phase	0	0	55
Extension Phase Participants who received DP Batch B ≥ 50% of the weeks, at Week 16 in the extension phase	0	0	94
Extension Phase Participants who received only DP Batch A in the extension phase	0	0	20
Extension Phase Participants who received DP Batch B for all or a portion of the extension phase	0	0	129
Extension Phase Participants who received DP Batch A >50% of the weeks, at Week 8 in the extension phase	0	0	81
Extension Phase Participants who received DP Batch B ≥ 50% of the weeks, at Week 8 in the extension phase	0	0	68
Extension Phase COMPLETED	0	0	122
Extension Phase NOT COMPLETED	0	0	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RewinD-LB - Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neflamapimod n=79 Participants Arm of trial including the 79 participants that were randomly assigned (1:1) to take neflamapimod (active study drug) for 16 weeks during the blinded period.	Placebo n=80 Participants Arm of trial including the 80 participants that were randomly assigned (1:1) to take placebo for 16 weeks during the blinded period.	Total n=159 Participants Total of all reporting groups
Age, Continuous	72.1 years STANDARD_DEVIATION 6.4 • n=136 Participants	70.7 years STANDARD_DEVIATION 5.8 • n=136 Participants	71.4 years STANDARD_DEVIATION 6.1 • n=272 Participants
Sex: Female, Male Female	10 Participants n=136 Participants	13 Participants n=136 Participants	23 Participants n=272 Participants
Sex: Female, Male Male	69 Participants n=136 Participants	67 Participants n=136 Participants	136 Participants n=272 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants
Race (NIH/OMB) Asian	1 Participants n=136 Participants	0 Participants n=136 Participants	1 Participants n=272 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=136 Participants	1 Participants n=136 Participants	1 Participants n=272 Participants
Race (NIH/OMB) Black or African American	2 Participants n=136 Participants	2 Participants n=136 Participants	4 Participants n=272 Participants
Race (NIH/OMB) White	74 Participants n=136 Participants	76 Participants n=136 Participants	150 Participants n=272 Participants
Race (NIH/OMB) More than one race	1 Participants n=136 Participants	0 Participants n=136 Participants	1 Participants n=272 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=136 Participants	1 Participants n=136 Participants	2 Participants n=272 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=136 Participants	2 Participants n=136 Participants	7 Participants n=272 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=136 Participants	78 Participants n=136 Participants	152 Participants n=272 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Includes all participants who had analyzable results at Baseline and Week 16

Outcome measures

Outcome measures
Measure	Neflamapimod n=79 Participants Arm of trial including the 79 participants that were randomly assigned (1:1) to take neflamapimod (active study drug) for 16 weeks during the blinded period.	Placebo n=79 Participants Arm of trial including the 80 participants that were randomly assigned (1:1) to take placebo for 16 weeks during the blinded period.
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)	0.36 Scores on a scale Standard Error 0.193	0.34 Scores on a scale Standard Error 0.188

SECONDARY outcome

Timeframe: 16 weeks

Population: Includes all participants who had analyzable results at Baseline and Week 16

Evaluate if neflamapimod improves motor function in participants with DLB, compared to placebo, as assessed by the TUG test. TUG scores typically range from 6 to 20 seconds with a higher score indicating worse mobility. A score of \>15 indicates an increased risk of falls.

Outcome measures

Outcome measures
Measure	Neflamapimod n=79 Participants Arm of trial including the 79 participants that were randomly assigned (1:1) to take neflamapimod (active study drug) for 16 weeks during the blinded period.	Placebo n=78 Participants Arm of trial including the 80 participants that were randomly assigned (1:1) to take placebo for 16 weeks during the blinded period.
Change in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)	0.28 Seconds Standard Error 1.070	0.03 Seconds Standard Error 1.030

SECONDARY outcome

Timeframe: 16 weeks

Population: Includes all participants who had analyzable results at Baseline and Week 16

Evaluate if neflamapimod improves cognition, compared to placebo, as assessed by a DLB-specific NTB in participants with DLB. NTB includes Cogstate Detection test (DET), Cogstate Identification test (IDN), Cogstate One Card Learning test (OCL), Cogstate One Back test (ONB). Each score on the individual tests is converted to a z-score, and then a total z-score for the composite is calculated, in which each test is weighted equally. As the analysis is based on z-scores, there is no minimum or maximum value. A z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in z-score indicates an improvement in cognition and a negative change in z-score indicates a worsening in cognition.

Outcome measures

Outcome measures
Measure	Neflamapimod n=67 Participants Arm of trial including the 79 participants that were randomly assigned (1:1) to take neflamapimod (active study drug) for 16 weeks during the blinded period.	Placebo n=72 Participants Arm of trial including the 80 participants that were randomly assigned (1:1) to take placebo for 16 weeks during the blinded period.
Change in the Composite Score of the Neuropsychological Test Battery (NTB), Including Tests of Attention, Executive Function, and Visual Learning in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)	0.05 Z-score Standard Error 0.052	0.07 Z-score Standard Error 0.048

SECONDARY outcome

Timeframe: 16 weeks

Population: Includes all participants who had analyzable results at Baseline and Week 16

Evaluate if neflamapimod improves global (cognition, function and behavior) disease status evaluated by a clinician with caregiver input, compared to placebo, in participants with DLB, as assessed ADCS-CGIC score. ADCS-CGIC scores range from 1 to 7, where 1 = marked improvement, 2= moderate improvement, 3 = minimal improvement, 4 = no change, 5 = minimal worsening, 6 = moderate worsening, and 7 = marked worsening.

Outcome measures

Outcome measures
Measure	Neflamapimod n=78 Participants Arm of trial including the 79 participants that were randomly assigned (1:1) to take neflamapimod (active study drug) for 16 weeks during the blinded period.	Placebo n=78 Participants Arm of trial including the 80 participants that were randomly assigned (1:1) to take placebo for 16 weeks during the blinded period.
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-GCIC) Score at Week 16 in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)	4.4 Scores on a scale Standard Deviation 0.93	4.5 Scores on a scale Standard Deviation 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks of the extension phase

Population: Participants who had analyzable results at Start, Week 8 or Week 16 of the extension phase

Evaluate the efficacy of neflamapimod, in recipients of Drug Product (DP) Batch A compared to Drug Product (DP) Batch B, as a treatment for DLB, as assessed by the CDR-SB scale. CDR-SB scores range from 0 to 18 with a higher score indicating worsening of cognitive impairment.

Outcome measures

Outcome measures
Measure	Neflamapimod n=49 Participants Arm of trial including the 79 participants that were randomly assigned (1:1) to take neflamapimod (active study drug) for 16 weeks during the blinded period.	Placebo n=87 Participants Arm of trial including the 80 participants that were randomly assigned (1:1) to take placebo for 16 weeks during the blinded period.
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)	1.1 Scores on a scale Standard Error 0.29	0.63 Scores on a scale Standard Error 0.21

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks of the extension phase

Population: Participants who had analyzable results at Start, Week 8 or Week 16 of the extension phase

Evaluate if neflamapimod improves motor function in participants with DLB, in recipients of Drug Batch A compared to Drug Batch B, as assessed by the TUG test. TUG scores typically range from 6 to 20 seconds with a higher score indicating worse mobility. A score of \>15 indicates an increased risk of falls.

Outcome measures

Outcome measures
Measure	Neflamapimod n=49 Participants Arm of trial including the 79 participants that were randomly assigned (1:1) to take neflamapimod (active study drug) for 16 weeks during the blinded period.	Placebo n=82 Participants Arm of trial including the 80 participants that were randomly assigned (1:1) to take placebo for 16 weeks during the blinded period.
Change in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)	0.85 Seconds Standard Error 0.46	0.03 Seconds Standard Error 0.36

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks of the extension phase

Population: Participants who had analyzable results at Start, Week 8 or Week 16 of the extension phase

Evaluate if neflamapimod improves cognition, in recipients of Drug Product (DP) Batch A compared to Drug Product (DP) Batch B as assessed by a DLB-specific NTB in participants with DLB. NTB includes Cogstate Detection test (DET), Cogstate Identification test (IDN), Cogstate One Card Learning test (OCL), Cogstate One Back test (ONB). Each score on the individual tests is converted to a z-score, and then a total z-score for the composite is calculated, in which each test is weighted equally. As the analysis is based on z-scores, there is no minimum or maximum value. A z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in z-score indicates an improvement in cognition and a negative change in z-score indicates a worsening in cognition.

Outcome measures

Outcome measures
Measure	Neflamapimod n=39 Participants Arm of trial including the 79 participants that were randomly assigned (1:1) to take neflamapimod (active study drug) for 16 weeks during the blinded period.	Placebo n=73 Participants Arm of trial including the 80 participants that were randomly assigned (1:1) to take placebo for 16 weeks during the blinded period.
Change in the Composite Score of the Neuropsychological Test Battery (NTB), Including Tests of Attention, Executive Function, and Visual Learning in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)	-0.09 Z-score Standard Error 0.08	-0.06 Z-score Standard Error 0.05

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

Population: Participants who had analyzable results at Week 8 of the extension phase

Evaluate if neflamapimod improves global (cognition, function and behavior) disease status evaluated by a clinician with caregiver input, in recipients of Drug Product (DP) Batch A compared to Drug Product (DP) Batch B, in patients with DLB, as assessed ADCS-CGIC score. ADCS-CGIC scores range from 1 to 7, where 1 = marked improvement, 2= moderate improvement, 3 = minimal improvement, 4 = no change, 5 = minimal worsening, 6 = moderate worsening, and 7 = marked worsening.

Outcome measures

Outcome measures
Measure	Neflamapimod n=74 Participants Arm of trial including the 79 participants that were randomly assigned (1:1) to take neflamapimod (active study drug) for 16 weeks during the blinded period.	Placebo n=63 Participants Arm of trial including the 80 participants that were randomly assigned (1:1) to take placebo for 16 weeks during the blinded period.
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Score at Week 8 in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (Extension Phase)	4.42 Scores on a scale Standard Error 0.12	4.02 Scores on a scale Standard Error 0.15

OTHER_PRE_SPECIFIED outcome

Timeframe: 32 weeks

Population: Participants who had analyzable results at Start and Week 32 of the extension phase

Change from Start of Extension Phase in GFAP levels in neflamapimod-treated participants, Drug Product (DP) Batch A compared to Drug Product (DP) Batch B, over 32 weeks. GFAP in plasma is measured in pg/mL (picograms per milliliter) and a reduction in levels is associated with clinical improvement

Outcome measures

Outcome measures
Measure	Neflamapimod n=12 Participants Arm of trial including the 79 participants that were randomly assigned (1:1) to take neflamapimod (active study drug) for 16 weeks during the blinded period.	Placebo n=107 Participants Arm of trial including the 80 participants that were randomly assigned (1:1) to take placebo for 16 weeks during the blinded period.
Exploratory Outcome - Plasma Biomarker, Glial Fibrillary Acidic Protein (GFAP), Measurement at Week 32 (Extension Phase)	10.49 pg/mL Interval -6.472 to 27.45	-18.4 pg/mL Interval -26.18 to -10.62

Adverse Events

Neflamapimod

Serious events: 5 serious events

Other events: 58 other events

Deaths: 0 deaths

Placebo

Serious events: 8 serious events

Other events: 58 other events

Deaths: 2 deaths

Open-label Extension

Serious events: 22 serious events

Other events: 61 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Neflamapimod n=79 participants at risk Arm of trial including the 79 participants that were randomly assigned (1:1) to take neflamapimod (active study drug) for 16 weeks during the blinded period.	Placebo n=80 participants at risk Arm of trial including the 80 participants that were randomly assigned (1:1) to take placebo for 16 weeks during the blinded period.	Open-label Extension n=149 participants at risk Arm of trial including the 149 participants that continued to the open-label extension where all participants received neflamapimod (active study drug) for 32 weeks.
Injury, poisoning and procedural complications Fall	15.2% 12/79 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	18.8% 15/80 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	16.8% 25/149 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.
Infections and infestations COVID-19	10.1% 8/79 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	3.8% 3/80 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	6.0% 9/149 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.
Gastrointestinal disorders Diarrhea	7.6% 6/79 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	3.8% 3/80 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	5.4% 8/149 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.
Infections and infestations Urinary tract infection	6.3% 5/79 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	7.5% 6/80 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	7.4% 11/149 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.
Infections and infestations Upper respiratory tract infection	6.3% 5/79 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	5.0% 4/80 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	4.0% 6/149 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.
Nervous system disorders Headache	6.3% 5/79 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	12.5% 10/80 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	4.7% 7/149 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.
General disorders Fatigue	6.3% 5/79 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	7.5% 6/80 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	4.7% 7/149 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.
Nervous system disorders Dizziness	5.1% 4/79 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	3.8% 3/80 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	4.7% 7/149 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.
Psychiatric disorders Confusional state	5.1% 4/79 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	1.2% 1/80 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	3.4% 5/149 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.
Investigations Alanine aminotransferase increased	5.1% 4/79 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	1.2% 1/80 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	2.7% 4/149 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.
Musculoskeletal and connective tissue disorders Back pain	5.1% 4/79 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	1.2% 1/80 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	2.7% 4/149 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.
Psychiatric disorders Hallucination	2.5% 2/79 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	6.2% 5/80 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.	5.4% 8/149 • Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history. Any sign, symptom, or disease present before starting the treatment period were only considered AEs if they worsened after starting the treatment period. AEs were collected for participants in placebo (blinded only) and neflamapimod (blinded and open-label) groups. AEs were not collected by DP batch groups.

Additional Information

Mark De Rosch, Executive Vice President, Regulatory and Government Affairs, and Program Management

EIP Pharma/CervoMed Inc

Phone: (617) 744-4400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60