Longitudinal study on Alzheimer's disease and related conditions
Rocky Mountain Alzheimer's Disease Center at the University of Colorado School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and Clinical Phenotyping Study
University of Colorado, Denver · NCT02612376
This study is trying to gather blood, brain fluid, and imaging data from people with Alzheimer's, Down Syndrome, and Mild Cognitive Impairment to better understand these conditions and find new treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT02612376 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a comprehensive bank of blood, cerebrospinal fluid, imaging, and clinical data to investigate the causes of Alzheimer's disease, Down Syndrome, and Mild Cognitive Impairment. By collecting and analyzing these samples and data, the study seeks to enhance understanding of these conditions and evaluate the effectiveness of potential treatments. Participants will include individuals diagnosed with age-related cognitive impairments and community-dwelling controls over the age of 60.
Who should consider this trial
Good fit: Ideal candidates include individuals aged over 60 with a clinical diagnosis of mild cognitive impairment or Alzheimer's disease, as well as healthy community-dwelling controls.
Not a fit: Patients with significant medical, neurological, or psychiatric conditions that could confound study results may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of new treatments and improved understanding of Alzheimer's disease and related cognitive disorders.
How similar studies have performed: Other studies focusing on biomarker collection and longitudinal data analysis in Alzheimer's disease have shown promise, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aurora, Colorado
- University of Colorado, Denver — Aurora, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Brianne M Bettcher, PhD — University of Colorado, Denver
- Study coordinator: Bela Romano
- Email: ISABELA.ROMANO@CUANSCHUTZ.EDU
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Disease, Down Syndrome, Mild Cognitive Impairment