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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Down Syndrome; Mild Cognitive Impairment

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Bela Romano; Email: ISABELA.ROMANO@CUANSCHUTZ.EDU
• Study Contact Backup: Name: Franklin Roberts; Email: FRANKLIN.ROBERTS@CUANSCHUTZ.EDU

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado, Denver
      • Contact: Brianne Bettcher, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimated): November 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Congenital Abnormalities; Genetic Diseases, Inborn; Neurodegenerative Diseases; Intellectual Disability; Dementia; Tauopathies; Cognition Disorders; Abnormalities, Multiple; Chromosome Disorders; Alzheimer Disease; Cognitive Dysfunction; Down Syndrome
• Other Study ID Numbers: 15-1774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO