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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT02612376
Collaborator
(none)
800
Enrollment
1
Location
95
Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Rocky Mountain Alzheimer's Disease Center at the University of Colorado School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and Clinical Phenotyping Study
    Study Start Date :
    Feb 1, 2016
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    AD, DS, Mild Cognitive Impairment

    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

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Longitudinal collection of biospecimens and data from participants with MCI, AD, DS, healthy controls, and parents of DS individuals. [Annually for 15 years or death]

      Whichever occurs first.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Persons with age-related MCI or AD according to clinical diagnosis, consistent with NIA-AA diagnostic criteria

    2. Individuals with DS according to clinical diagnosis, with cognitive ability sufficient to follow directions, Age > 30 years

    3. Non-DS community-dwelling controls, Age > 60 years

    4. Non-pregnant mothers and fathers of DS individuals (controls)

    5. Ability to complete baseline assessments

    6. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado, Denver Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: Brianne M Bettcher, PhD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT02612376
    Other Study ID Numbers:
    • 15-1774
    First Posted:
    Nov 23, 2015
    Last Update Posted:
    Jun 28, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Alzheimer Disease
    Down Syndrome
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Jun 28, 2021