Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The current study aims to validate several novel cognitive tasks expected to be sensitive to brain impairment in specific anatomic regions affected in preclinical Alzheimer's disease(pAD). The tasks are validated in 60 cognitively and clinically normal participants ages 60 - 85, inclusive, against reasonably well-established biomarkers of Alzheimer's disease, including 1) simultaneous positron emission tomography (PET) [18F]Flutemetamol amyloid and CT imaging and 2) to the extent data is available from other studies, participants' brain MRI and cerebral spinal fluid (CSF) amyloid and tau.
Biomarkers, such as amyloid deposition, and Hipp volume loss, and low Aβ and high pTau in CSF, are useful for identifying cognitively normal (CN) elderly who are likely have early AD pathology ("preclinical AD"). However, they are invasive and/or expensive. The goal of the current study is to develop and validate cognitive proxies of AD biomarkers by using cognitive tasks that are dependent on brain regions impaired by very early AD pathology. If successful, these tasks will provide a non-invasive and cost-effective way to identify and track change in CN individuals at high risk for progressing to mild cognitive impairment (MCI) and dementia stages of AD and thus will facilitate future prevention trials in pAD.
Subjects will attend three study visits. During the first study visit, subjects will have eligibility criteria confirmed, have a blood sample drawn, and complete about half of the cognitive tasks. The second visit, which will occur within one week of visit one, will involve completion of the remaining cognitive tasks. Subjects will also be asked to have a PET-CT scan during visit three (to occur within 3 months of visits 1 and 2).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitively Normal | Participants will be deemed cognitively normal based on criteria set forth by the National Alzheimer's Disease Coordinating Center/Alzheimer's Disease Centers (ADCC/ADC). | ||
| Amnestic Mild Cognitive Impairment (aMCI) | Participants will be deemed aMCI based on criteria set forth by the National Alzheimer's Disease Coordinating Center/Alzheimer's Disease Centers (ADCC/ADC). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of composite score on cognitive tests with biomarkers | The overall score on the cognitive tests will be correlated via a linear regression with biomarker data collected during the study. Each biomarker will be regressed individually. Biomarker data includes: MRI hippocampus (hipp) volume, entorhinal cortex (EC) volume, EC standard uptake value ratios (SUVRs), Hipp SUVR, precuneus (PCu) SUVR, PET-[18F] Flutemetamol SUVR, CSF Aβ and tau levels, levels of diffusion tensor imaging mean diffusivity, and levels of fractional anisotropy. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of ApoE allele | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Participants will be elderly individuals who are participating in ongoing clinical research at the NYU CCN, including at the ADC and the Center for Brain Health (CBH). Participants may also be recruited through community outreach or referrals from other centers. Cognitively normal (CN) participants and participants with amnestic mild cognitive impairment (aMCI) will be enrolled.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin Sadowski, PhD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | United States |
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Any remaining blood specimens will be retained indefinitely for future use by the Center for Cognitive Neurology (CCN) at NYU Langone Medical Center. Some samples may also be sent to Janssen Research & Development, LLC for potential future research use. Potential future research use by study investigators or collaborators will include possible discovery of novel biomarkers associated with increased AD risk, and study of validity of the use of such markers in preclinical AD. True genetic testing will not be done on these samples.
Subjects may decline to have their samples stored for future use by checking the applicable box on the informed consent form. Subjects who agreed to have their samples stored for future use may revoke this permission.