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

Study Overview
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Brief Summary
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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.

Official Title
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Rocky Mountain Alzheimer's Disease Center at the University of Colorado School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and Clinical Phenotyping Study

Conditions
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Alzheimer Disease, Down Syndrome, Mild Cognitive Impairment

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons with age-related MCI or AD according to clinical diagnosis, consistent with NIA-AA diagnostic criteria Individuals with DS according to clinical diagnosis, with cognitive ability sufficient to follow directions, Age > 30 years Non-DS community-dwelling controls, Age > 60 years Non-pregnant mothers and fathers of DS individuals (controls) Ability to complete baseline assessments 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 for Non-Down Syndrome participants

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AD, DS, Mild Cognitive Impairment<br>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. Individuals with Down Syndrome (DS) according to clinical diagnosis, with cognitive ability sufficient to follow directions. | |
| Healthy Controls<br>Non-DS community-dwelling controls Non-pregnant mothers and fathers of DS individuals (controls) An Informant (study partner) available to complete functional interviews/survey measures annually. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal collection of biospecimens and data from participants with MCI, AD, DS, healthy controls, and parents of DS individuals. | Whichever occurs first. | Annually for 15 years or death |