Cognitive Detection of Preclinical AD: Validation Using Biomarkers

NCT02616679 | Completed

• 1 other identifier: 13-00706
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Presence of ApoE allele

  3 months

Study Arms (2)

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).

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Prior enrollment as a participant in the NYU Alzheimer's Disease Center (ADC) and completion of the ADC Clinical Evaluation within the past year.
• Clinical diagnosis of "cognitively normal" or "amnestic mild cognitive impairment" based on recent (within 1 year) consensus meeting cross-referenced with standard neuropsychological scores.
• Normal or corrected-to-normal vision and hearing (able to see images on computer screen and hear auditory events delivered through the computer speaker).

You may not qualify if:

• Significant history of mental illness, drug or alcohol abuse; severe trauma preventing normal use of dominant hand (needed to move the mouse cursor); clinical depression (unless medically controlled); other neurologic conditions (i.e. stroke), or learning disability; ophthalmologic/visual problems that prevent viewing a computer screen at a normal distance (such as legal blindness, detached retinas, occlusive cataracts).
• Lack of capacity to give informed consent and no legally authorized representative to provide consent.
• Having pacemakers, aneurysm clips, cochlear implants, or metal/foreign objects in body and therefore, unable to receive MRI.
• Pregnancy, breastfeeding or planning to have a baby.

Sponsors & Collaborators

• NYU Langone Health: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Martin Sadowski, PhD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: November 30, 2015
• Study Start: January 5, 2016
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

US (1)