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ADRC Clinical Cohort (Alzheimer's Disease)

Duke/UNC Alzheimer's Disease Center Clinical Cohort

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Physical exams, Blood draws, Urine samples, MRI scans, PET scans, Spinal tap (lumbar puncture)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 will undergo baseline data collection according to the Uniform Data Set, version 3 set forth by the National Alzheimer's Coordinating Center including medical and family history, physical exam, neuropsychological testing, blood and urine sample, cerebrospinal fluid sample, and brain MRI."
  • "Subjects in the ages 45 to 80 group will be re-evaluated every year with a medical history update, physical exam, and neuropsychological testing."
  • "A subset of the cohort ages 45 to 80, unable or unwilling to have the Lumbar Puncture, may alternately be offered to supplement a PET Scan to confirm diagnosis if/when AD symptoms are present."
  • "Subjects will have an initial visit with information/history gathering, physical exam, neuropsychological testing, and blood draw."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how memory and thinking change with age, including changes linked to Alzheimer's disease and related dementias. It also studies how genes, health, diet, and medicines may affect risk. It is for adults ages 25–44 with normal memory and thinking, and adults ages 45–80 with normal thinking, mild problems, or dementia.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 25–80 years old.
  • Be able to read at a 6th-grade level, as judged by the study team.
  • Have a school or work history that shows no intellectual disability, which affects learning and daily skills.
  • You or your legal representative must sign a consent form before screening tests.
  • Be willing to have an MRI, a scan that takes pictures inside the body.
  • Be willing to have a spinal tap to collect fluid around the brain and spine, or a series of PET imaging scans instead.
  • If you are 45–80, have a study partner who agrees to take part. They must read at a 6th-grade level and have a school or work history that shows no intellectual disability.

Who can't join

  • A serious or unstable brain or nerve condition, such as repeated head injuries, stroke, multiple sclerosis, or Parkinson's disease.
  • A serious or unstable mental health condition.
  • Alcohol or drug abuse or dependence within the past 2 years.
  • A score above 9 on either the GAD-7 anxiety survey or the PHQ-8 depression survey.
  • An uncontrolled health condition that the study doctor believes would make taking part unsafe.
  • Being unable to safely have or tolerate a 3T MRI scan, including because of an implanted device.
  • Cancer in any organ within the past 5 years, whether treated or not. Exceptions include certain skin cancers and cervical cancer that has not spread beyond the surface cells. Local tumors that are not cancer and do not need whole-body chemotherapy or radiation are also allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Evidence of a clinically relevant or unstable neurological disorder including history of multiple head injuries, stroke or other CNS conditions (MS, Parkinson's disease, etc.) * Evidence of a clinically relevant or unstable psychiatric disorder. * History of alcoholism or drug dependency/abuse within the last 2 years before enrollment. * GAD-7 score \>9 and/or PHQ-8 score \>9 * An ongoing uncontrolled, clinically significant medical condition such that, in the judgment of the investigator, a subject's participation in the trial would pose a significant medical risk to the subject. * Contraindication or intolerance to 3T MRI investigations, including implanted devices * History of malignancy of any organ system, treated or untreated, within the past 60 months, regardless of whether there is evidence of local recurrence or metastases. However localized nonmalignant tumors not requiring systemic chemo- or radiotherapy, localized basal or squamous cell carcinoma of the skin, or in-situ cervical cancer are permitted.

Study sites (1)

NC