Cognitive Detection of Preclinical AD: Validation Using Biomarkers
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Observational

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.
    

Detailed description: 
      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).
    

Observational model: Cohort
Time perspective: Cross-Sectional
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.
      
Biospecimen description: 
      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.