Cognitive Detection of Preclinical AD: Validation Using Biomarkers
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - 85 |
| Updated: | 1/31/2019 |
| Start Date: | January 2016 |
| End Date: | September 2019 |
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.
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).
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).
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
We found this trial at
1
site
Click here to add this to my saved trials
