An interventional study of BAY 94-9172 (Florbetaben) in Late Onset Alzheimer Disease, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Diagnostic
The overall goal of this project is to establish and validate biomarkers associated with the risk and progression of late onset Alzheimer's disease, mild cognitive impairment and cognitive decline. The investigators will use baseline and longitudinal measurements of plasma amyloid beta-40 and amyloid beta-42 to investigate the risk of developing mild cognitive impairment and late onset Alzheimer's disease, as well as the rates of cognitive decline and Alzheimer's disease progression. The driving hypothesis of the study is that amyloid beta in the brain as measured by positron emission tomography positivity is associated with the onset of cognitive decline associated with late onset Alzheimer's disease.
This project is a sub-study of the Washington Heights-Inwood Community Aging Project, which is a multidisciplinary, epidemiological study of Alzheimer's disease and related neurodegenerative disorders. We will obtain positron emission tomography scans and simultaneous x-ray computed tomography scans using Florbetaben from Bayer on a selection of ongoing participants who will be selected on the basis of change in plasma levels of amyloid beta over time. Approximately 200 participants will receive scans beginning in 2009 and in the 2010-2012 assessment wave and then again in a 2014-2015 assessment wave. Our intention is to examine whether uptake of Florbetaben in the brain is associated with decline in cognition over the 10 years prior to the PET scan.
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's enrollment of 161 is above the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →New York State Psychiatric Institute is the lead sponsor of 433 studies on the registry; 25 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
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BAY 94-9172 PET/CT
Drug: BAY 94-9172 (Florbetaben)
Measure of brain amyloid load using BAY 94-9172 PET/CT
Also known as: Florbetaben, Bay 91-9172
Relationship Between Cognitive Change Over Time and Amyloid (Aβ) Deposition
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.
Time frame: up to 3 years and 10 months
| Milestone | BAY 94-9172 |
|---|---|
| Started | 160 |
| Completed | 160 |
| Not completed | 0 |
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.
| Participants | BAY 94-9172 |
|---|---|
| Participant with positive amyloid reading | 41 |
| Participant without positive amyloid reading | 75 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BAY 94-9172 | 0/160 (0%) | 0/160 (0%) | 0/160 (0%) |
| Age, Categorical(Participants) | BAY 94-9172 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 160 |
| Sex: Female, Male(Participants) | BAY 94-9172 |
|---|---|
| Female | 102 |
| Male | 58 |
| Ethnicity (NIH/OMB)(Participants) | BAY 94-9172 |
|---|---|
| Hispanic or Latino | 37 |
| Not Hispanic or Latino | 123 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | BAY 94-9172 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 67 |
| White | 58 |
| More than one race | 12 |
| Unknown or Not Reported | 23 |
| Region of Enrollment(participants) | BAY 94-9172 |
|---|---|
| United States | 160 |
Ran from Dec 2010 to primary completion in Oct 2014, 46 months.
Results were first posted in May 2024, 9 years 6 months after primary completion.
Of 806 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's 46 months is above that.
Counting every sponsor, half of 874 studies reached it within 31 months; a quarter within 15 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Florbetaben f-18
New York State Psychiatric Institute →