Alzheimer DiseaseNCT02612376
Rocky Mountain Alzheimer's Disease Center Longitudinal Biomarker and Clinical Phenotyping Study
An observational study of Alzheimer Disease and Down Syndrome, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Down Syndrome, Mild Cognitive Impairment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to May 2025
- How long will I take part?
- 25 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participants with Mild Cognitive Impairment (MCI), AD, healthy controls
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Denver
Aurora, Colorado, 80045
About this study
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
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
- Medical subject headings
- Alzheimer Disease, Down Syndrome, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal collection of biospecimens and data from participants with MCI, AD, DS, healthy controls, and parents of DS individuals.
Whichever occurs first.
Measured: Annually for 15 years or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionApr 2025
- Study completionMay 2025
Why it stopped: Loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brianne M Bettcher, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612376
- Sponsor's protocol ID
- 15-1774
- Status last verified
- May 2025
- First submitted
- 13 Nov 2015
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No