Trial Outcomes & Findings for A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities (NCT NCT03639987)
NCT ID: NCT03639987
Last Updated: 2021-09-16
Results Overview
TERMINATED
PHASE2
52 participants
up to Week 54
2021-09-16
Participant Flow
Participants were enrolled at 10 investigative sites in the United States from 20 December 2018 to 30 July 2019.
A total of 52 participants with Alzheimer's disease were enrolled in this study in one of the 2 groups: Group 1 and Group 2 to receive aducanumab titrated up to 10 mg/kg. The groups differed in the protocol specified management rules for amyloid-related imaging abnormalities (ARIA), in the event that moderate or severe asymptomatic ARIA was detected on MRI.
Participant milestones
| Measure |
Group 1
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
|
Group 2
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
26
|
26
|
Reasons for withdrawal
| Measure |
Group 1
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
|
Group 2
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
|
|---|---|---|
|
Overall Study
Study terminated by sponsor
|
26
|
25
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities
Baseline characteristics by cohort
| Measure |
Group 1
n=26 Participants
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
|
Group 2
n=26 Participants
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.5 years
STANDARD_DEVIATION 7.17 • n=39 Participants
|
73.3 years
STANDARD_DEVIATION 7.14 • n=41 Participants
|
72.9 years
STANDARD_DEVIATION 7.09 • n=35 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
49 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=39 Participants
|
26 Participants
n=41 Participants
|
52 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: up to Week 54Population: Clinically Impactful ARIA was to be assessed by an independent Adjudication Committee. At the time the study was terminated, the Adjudication Committee had not been formed; therefore, this outcome measure was not evaluated due to lack of data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Week 54Population: The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
ARIA by severity was obtained on Magnetic Resonance Imaging (MRI).
Outcome measures
| Measure |
Group 1
n=26 Participants
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
|
Group 2
n=26 Participants
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
|
|---|---|---|
|
Number of Participants With ARIA by Severity as Obtained on Magnetic Resonance Imaging (MRI)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to Week 54Population: Due to small number of ARIA events, data is not reported due to participant confidentiality/human subjects protection assurances.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Week 54Population: Due to small number of ARIA events, data is not reported due to participant confidentiality/human subjects protection assurances.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Week 54Population: The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
ARIA by severity was obtained on Magnetic Resonance Imaging (MRI).
Outcome measures
| Measure |
Group 1
n=26 Participants
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
|
Group 2
n=26 Participants
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
|
|---|---|---|
|
Number of Participants With Symptomatic ARIA by Severity
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to Week 54Population: Due to small number of ARIA events, data is not reported due to participant confidentiality/human subjects protection assurances.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Week 54Population: Due to small number of ARIA events, data is not reported due to participant confidentiality/human subjects protection assurances.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Week 54Population: The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.
Outcome measures
| Measure |
Group 1
n=26 Participants
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
|
Group 2
n=26 Participants
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
15 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 54Population: Due to early termination of the study, none of the participants reached the week 54 timepoint; therefore, data is not available for analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Week 54Population: The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
Outcome measures
| Measure |
Group 1
n=26 Participants
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
|
Group 2
n=26 Participants
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
|
|---|---|---|
|
Number of Participants With Aducanumab Concentration in Serum
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to Week 54Population: The safety population is defined as all randomized participants who received at least one dose of aducanumab.
Outcome measures
| Measure |
Group 1
n=26 Participants
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
|
Group 2
n=26 Participants
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
|
|---|---|---|
|
Number of Participants With Antiaducanumab Antibodies in Serum
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1
Group 2
Serious adverse events
| Measure |
Group 1
n=26 participants at risk
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
|
Group 2
n=26 participants at risk
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
2/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
0.00%
0/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
3.8%
1/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
0.00%
0/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
3.8%
1/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
0.00%
0/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
|
Cardiac disorders
Bradycardia
|
3.8%
1/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
0.00%
0/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
Other adverse events
| Measure |
Group 1
n=26 participants at risk
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 1 ARIA management rules.
|
Group 2
n=26 participants at risk
Aducanumab dose titrated up to 10 mg/kg, IV infusion, following Group 2 ARIA management rules.
|
|---|---|---|
|
Nervous system disorders
Headache
|
19.2%
5/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
15.4%
4/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
1/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
7.7%
2/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
|
Injury, poisoning and procedural complications
Fall
|
11.5%
3/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
0.00%
0/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
7.7%
2/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
|
Nervous system disorders
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
|
7.7%
2/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
0.00%
0/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
|
Psychiatric disorders
Depression
|
7.7%
2/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
0.00%
0/26 • Up to Week 54
The safety population is defined as all randomized participants who had received at least one dose of aducanumab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER