Rocky Mountain Alzheimer's Disease Center Longitudinal Biomarker and Clinical Phenotyping Study

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Down Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT02612376

15-1774

Details and patient eligibility

About

This study plans to establish a large bank of blood, cerebral spinal fluid (CSF), imaging, and clinical data. These data and samples will be used for future research into the causes of Alzheimer's disease (AD), Down Syndrome (DS) and other diseases that cause thinking and memory problems. This future research will also study how treatments for these diseases work. This research may help develop new treatments for some diseases of the nervous system and help understand these diseases better.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Persons with age-related MCI or AD according to clinical diagnosis, consistent with NIA-AA diagnostic criteria
2. Community-dwelling controls, Age > 60 years
3. Ability to complete baseline assessments
4. Has an informant (study partner) available to complete functional interviews/survey measures annually

Exclusion criteria

• Presence of concomitant medical, neurological, or psychiatric illness or condition that in the opinion of the investigators would confound interpretation of study results. These include: Korsakoff encephalopathy; active substance abuse; hepatitis C; opportunistic brain infection; brain tumor; active neoplastic disease (skin tumors other than melanoma are not exclusionary; participants with stable prostate cancer may be included at the discretion of the project director); multiple sclerosis; history of clinically significant stroke; current evidence or history in the past 2 years of focal brain lesion, head injury with loss of consciousness, or DSM-V criteria for any major psychiatric disorder, including psychosis, major depression, bipolar disorder, alcohol or substance abuse; blindness, deafness or any other disability which may prevent the participant from participating or cooperating in the protocol.
• Presence of contraindication for MRI scan

Trial design

800 participants in 2 patient groups

AD, DS, Mild Cognitive Impairment

Description:

Persons with age-related Mild Cognitive Impairment (MCI) or Alzheimer Disease (AD) according to clinical diagnosis, consistent with Alzheimer's Association (AA) and the National Institute on Aging (NIA) diagnostic criteria.

Healthy Controls

Description:

Community-dwelling controls An Informant (study partner) available to complete functional interviews/survey measures annually.