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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02612376
Other study ID # 15-1774
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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