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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02612376
• Other study ID #: 15-1774
• Status: Recruiting
• Start date: February 2016
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: Bela Romano
• Email: ISABELA.ROMANO[@]CUANSCHUTZ.EDU
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Down Syndrome
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	University of Colorado, Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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