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

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ClinicalTrials.gov Identifier: NCT02612376
Recruitment Status : Recruiting
First Posted : November 23, 2015
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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
Alzheimer Disease Down Syndrome Mild Cognitive Impairment

Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 25 Years
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 : February 2016
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030


Group/Cohort
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.



Primary Outcome Measures :
  1. Longitudinal collection of biospecimens and data from participants with MCI, AD, DS, healthy controls, and parents of DS individuals. [ Time Frame: Annually for 15 years or death ]
    Whichever occurs first.


Biospecimen Retention:   Samples With DNA
Biospecimens of blood and cerebral spinal fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
participants with Mild Cognitive Impairment (MCI), AD, DS, healthy controls, and parents of Down Syndrome individuals
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612376


Contacts
Contact: Nicola Haakonsen 303-724-4644 nicola.haakonsen@ucdenver.edu
Contact: Kate Heffernan 303-724-8971 kate.heffernan@ucdenver.edu

Locations
United States, Colorado
University of Colorado, Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Brianne Bettcher, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Brianne M Bettcher, PhD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02612376     History of Changes
Other Study ID Numbers: 15-1774
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Down Syndrome
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn