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

NCT02612376 | Terminated

• 1 other identifier: 15-1774
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Down Syndrome; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Healthy Controls

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

participants with Mild Cognitive Impairment (MCI), AD, healthy controls

You may qualify if:

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

You may not qualify if:

• Presence of contraindication for MRI scan

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens of blood and cerebral spinal fluid

MeSH Terms

Conditions

Alzheimer Disease; Down Syndrome; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Cognition Disorders

Study Officials

• Brianne M Bettcher, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 25 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 23, 2015
• Study Start: February 1, 2016
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)