Duke/UNC Alzheimer's Disease Center Clinical Cohort

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The purpose of the study is to establish a clinical cohort for the Duke/UNC Alzheimer's Disease Research Center (ADRC). The cohort will be composed of subjects ages 25 to 44 at enrollment with normal cognition and subjects ages 45 to 80 at enrollment with normal cognition, mild cognitive impairment, or a dementia diagnosis. Initial data including demographics, medical and family history, physical exam, and neuropsychological testing will be obtained. Participants will be asked to contribute a blood sample, a urine sample, a cerebrospinal fluid sample, and undergo a MRI scan. The cohort ages 45 to 80 will be seen yearly until death to evaluate medical status, undergo neuropsychological testing and possibly collect additional samples or undergo additional imaging. All data will be de-identified and stored by the ADRC. The purpose of this study is to examine normal cognition, mild cognitive impairment and Alzheimer's disease and related dementias (ADRD) as people get older. The investigators also hope to be able to assess risk factor information of the role of genes and environmental exposures (for example health conditions, diet, and medications) in Alzheimer's disease and related disorders (ADRD) and other conditions of aging. The biological samples collected in the study will create a repository. A repository is a collection of blood and tissue samples from people with certain diseases and conditions. For the purpose of this research, the investigators hope to help researchers learn more about Alzheimer's disease and related disorders and other conditions of aging.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 80
Healthy Volunteers: t
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• Each subject must be ≥ 25 to ≤ 80 years of age.

• Each subject must be able to read at a 6th grade level, as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude intellectual disability.

• Each subject (or legal representative) must sign the informed consent form after the scope and nature of the investigation have been explained to them, and before screening assessments. Some consent may be obtained via phone script and REDCap eConsent.

• Each participant must be willing to have an MRI and a lumbar puncture, or alternately (to the lumbar puncture) a series of PET scans.

• Each participant ages 45 to 80 must have a study partner who agrees to participate in the study and who is able to read at a 6th grade level, as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude intellectual disability.

Locations
United States
North Carolina
Duke University
RECRUITING
Durham
Contact Information
Primary
Rachel Dewees, MSW
adrc@duke.edu
919-660-2340
Time Frame
Start Date: 2020-07-21
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 500
Treatments
Participants aged 25-44
Subjects ages 25 to 44 at enrollment with normal cognition will undergo baseline visits including:~* Demographics~* Family history, medical history, current medications~* General physical and neurological exam, sensory and motor testing~* Vital signs~* Blood sample collected for PT/INR, blood count, genetic testing, and storage for future unspecified research on cognition and disorders associated with altered cognition~* Urine sample~* Neuropsychological testing~* Retinal imaging~* Testing of memory, thought processes, and recognition~* MRI~* Lumbar puncture
Participants aged 45-80
Subjects ages 45 to 80 at enrollment with normal cognition, mild cognitive impairment, or dementia will undergo baseline visits including:~* Demographics and project partner demographics~* Family history, medical history, current medications~* General physical and neurological exam, sensory and motor testing~* Vital signs~* Blood sample collected for PT/INR, blood count, genetic testing, and storage for future unspecified research on cognition and disorders associated with altered cognition~* Urine sample~* Neuropsychological testing~* Retinal imaging~* Testing of memory, thought processes, and recognition~* MRI~* Lumbar puncture~Participants will be asked to participate in yearly evaluations until the time of death. Participants can withdraw at any time.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: National Institute on Aging (NIA), University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov