Down Syndrome Clinical Trials - Study of Alzheimer's Disease in Down Syndrome
NCT ID: NCT04149197
Last Updated: 2024-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
252 participants
OBSERVATIONAL
2019-06-30
2024-04-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Memantine and Down's Syndrome
NCT00240760
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (HCl) (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome
NCT00570128
Down Syndrome Memantine Follow-up Study
NCT02304302
Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial
NCT00675025
Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation
NCT06911944
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This trial also aims to develop sensitive and well-validated assessment instruments of cognition, behavior and function appropriate for future clinical trials directed at AD-DS in adults with DS ages 25 and older.
In addition, this LIFE-DSR study will serve as a parent protocol that includes one or more sub-studies, each of which has its own protocol and consent form. These sub-studies will recruit from eligible participants enrolled in this LIFE-DSR protocol.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnosis of DS, typically supported by karyotype analysis documenting full trisomy for chromosome 21 or complete unbalanced translocation of chromosome 21. Karyotype analysis is not required for study entry
3. Participants, or Legal Authorized Representative, and their study partner if applicable, in the opinion of the investigator, are able to understand and willing to sign written informed consent.
4. Participants must have a study partner who has frequent interaction with the participant on a regular basis, will agree to participate in annual clinic visits, can provide accurate responses to questions about the participant, and facilitate participation in the study visits, in the opinion of site PI or study coordinator.
5. Participant and study partner must be capable of reliably completing study assessments.
25 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LuMind IDSC Foundation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lois Kelly
Role: STUDY_DIRECTOR
LuMind IDSC Foundation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barrow Neurological Institute
Phoenix, Arizona, United States
University California Irvine
Irvine, California, United States
University of California, San Diego
La Jolla, California, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Advocate Health
Park Ridge, Illinois, United States
Kansas University Medical Center
Fairway, Kansas, United States
University Of Kentucky
Lexington, Kentucky, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Charlestown, Massachusetts, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ADC-059-LIFE-DSR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.