Trial Outcomes & Findings for Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05 (NCT NCT02795780)

Last Updated: 2020-08-24

Results Overview

Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

79 participants

Primary outcome timeframe

18 months

Results posted on

2020-08-24

Participant Flow

Enrolled between Aug 2016 and Aug 2017. The only subjects eligible were those who completed the Confirmatory Phase of Study A05 (NCT02016560).

Participant milestones

Participant milestones
Measure	AD Subjects Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27	MCI Subjects Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
Overall Study STARTED	25	54
Overall Study COMPLETED	25	54
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AD Subjects n=25 Participants Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27 from the flortaucipir PET scan arm	MCI Subjects n=54 Participants Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27 from the flortaucipir PET scan arm	Total n=79 Participants Total of all reporting groups
Age, Continuous	73.8 years STANDARD_DEVIATION 10.63 • n=39 Participants	73.2 years STANDARD_DEVIATION 9.1 • n=41 Participants	73.4 years STANDARD_DEVIATION 9.54 • n=35 Participants
Sex: Female, Male Female	9 Participants n=39 Participants	22 Participants n=41 Participants	31 Participants n=35 Participants
Sex: Female, Male Male	16 Participants n=39 Participants	32 Participants n=41 Participants	48 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=39 Participants	3 Participants n=41 Participants	4 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=39 Participants	51 Participants n=41 Participants	75 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	3 Participants n=41 Participants	3 Participants n=35 Participants
Race (NIH/OMB) White	25 Participants n=39 Participants	51 Participants n=41 Participants	76 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
Region of Enrollment United States	25 participants n=39 Participants	54 participants n=41 Participants	79 participants n=35 Participants
MMSE	23.7 units on a scale STANDARD_DEVIATION 2.39 • n=39 Participants	25.9 units on a scale STANDARD_DEVIATION 1.48 • n=41 Participants	25.2 units on a scale STANDARD_DEVIATION 2.06 • n=35 Participants
CDR-SB	4.8 units on a scale STANDARD_DEVIATION 1.53 • n=39 Participants	2.6 units on a scale STANDARD_DEVIATION 1.91 • n=41 Participants	3.3 units on a scale STANDARD_DEVIATION 2.05 • n=35 Participants
Amyloid status Amyloid positive	19 Participants n=39 Participants	26 Participants n=41 Participants	45 Participants n=35 Participants
Amyloid status Amyloid Negative	6 Participants n=39 Participants	28 Participants n=41 Participants	34 Participants n=35 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Excluded 1 MCI Aβ+ and 1 MCI Aβ- subject for whom 18 month follow-up clinical was not available

Outcome measures

Outcome measures
Measure	AD Aβ+ Subjects n=19 Participants Amyloid positive AD subjects from the flortaucipir PET scan arm	AD Aβ- Subjects n=6 Participants Amyloid negative AD subjects from the flortaucipir PET scan arm	MCI Aβ+ Subjects n=26 Participants Amyloid positive MCI subjects from the flortaucipir PET scan arm	MCI Aβ- Subjects n=26 Participants Amyloid negative MCI subjects from the flortaucipir PET scan arm
Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status	0.0205 standardized uptake value ratio (SUVr) Standard Deviation 0.01871	-0.0912 standardized uptake value ratio (SUVr) Standard Deviation 0.03619	0.0352 standardized uptake value ratio (SUVr) Standard Deviation 0.01185	-0.0124 standardized uptake value ratio (SUVr) Standard Deviation 0.01185

Adverse Events

MCI Subjects

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

AD Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MCI Subjects n=54 participants at risk MCI subjects receiving a dose of flortaucipir	AD Subjects n=25 participants at risk AD subjects receiving a dose of flortaucipir
General disorders injection site pain	1.9% 1/54 • Number of events 1 • 48 hours after study drug administration Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.	0.00% 0/25 • 48 hours after study drug administration Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.
Nervous system disorders dizziness	1.9% 1/54 • Number of events 1 • 48 hours after study drug administration Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.	0.00% 0/25 • 48 hours after study drug administration Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.
Vascular disorders flushing	1.9% 1/54 • Number of events 1 • 48 hours after study drug administration Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.	0.00% 0/25 • 48 hours after study drug administration Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.

Additional Information

Medical Director

Avid Radiopharmaceuticals, Inc.

Phone: 215-298-0700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60