Trial Outcomes & Findings for Measuring Brain Amyloid Plaque Load in Older Adults Using BAY 94-9172 (NCT NCT01222351)

NCT ID: NCT01222351

Last Updated: 2024-05-06

Results Overview

We used PET imaging to measure presence of amyloid. The outcomes are cognitive z-scores, which had mean of zero and SD of 1, with no units. There are four cognitive domains (language, memory, processing speed, and visuospatial ability). Individual neuropsychological test Z-scores within each domain were averaged to get the mean domain z-scores. Finally, the four cognitive domain-specific Z-scores were then averaged into a global cognitive Z-score. A larger Z-score represents better cognitive performance. Latent growth curve model was used to test for the association between Aβ and cognitive change over time. The Beta weight is a coefficient from the model that indicates the difference in cognitive change between people with and without amyloid. A positive Beta weight indicates that Aβ deposition is associated with less decline in cognitive scores, a negative Beta weight indicates greater decline. The Beta weight is unitless, and it does not have a range.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 161 participants
• Primary outcome timeframe: up to 3 years and 10 months
• Results posted on: 2024-05-06

Participant Flow

Participant milestones

Measure	BAY 94-9172 BAY 94-9172 PET/CT BAY 94-9172 (Florbetaben): Measure of brain amyloid load using BAY 94-9172 PET/CT
Overall Study STARTED	160
Overall Study COMPLETED	160
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measuring Brain Amyloid Plaque Load in Older Adults Using BAY 94-9172

Baseline characteristics by cohort

Measure	BAY 94-9172 n=160 Participants BAY 94-9172 PET/CT BAY 94-9172 (Florbetaben): Measure of brain amyloid load using BAY 94-9172 PET/CT
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	160 Participants n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	123 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	67 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=5 Participants
Region of Enrollment United States	160 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 3 years and 10 months

Population: In this analysis we evaluated whether the presence of amyloid was related to previous decline in cognition in 116 subjects. Mean cognition summarized performance on several cognitive tests. were analyzed. Global amyloid burden was rated with a visual rating by 2 trained clinicians.

We used PET imaging to measure presence of amyloid. The outcomes are cognitive z-scores, which had mean of zero and SD of 1, with no units. There are four cognitive domains (language, memory, processing speed, and visuospatial ability). Individual neuropsychological test Z-scores within each domain were averaged to get the mean domain z-scores. Finally, the four cognitive domain-specific Z-scores were then averaged into a global cognitive Z-score. A larger Z-score represents better cognitive performance.

Latent growth curve model was used to test for the association between Aβ and cognitive change over time. The Beta weight is a coefficient from the model that indicates the difference in cognitive change between people with and without amyloid. A positive Beta weight indicates that Aβ deposition is associated with less decline in cognitive scores, a negative Beta weight indicates greater decline. The Beta weight is unitless, and it does not have a range.

Outcome measures

Measure	BAY 94-9172 n=116 Participants We used BAY 94-9172 (Florbetaben) to measure the presence of of brain amyloid.
Relationship Between Cognitive Change Over Time and Amyloid (Aβ) Deposition Participant with positive amyloid reading	41 Participants
Relationship Between Cognitive Change Over Time and Amyloid (Aβ) Deposition Participant without positive amyloid reading	75 Participants

Adverse Events

BAY 94-9172

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yaakov Stern

Columbia University

Phone: 212-342-1350

Email: ys11@columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place