TerminatedNot Applicable

Down Syndrome Clinical Trials - Study of Alzheimer's Disease in Down Syndrome

Stopped: COVID delayed study timelines. Competing studies began enrolling at our sites.

United States252 participantsStarted 2019-06-30

Plain-language summary

The primary objective is to characterize trajectories of change on the primary outcome measures in this study population through longitudinal collection of measures of cognition, function, behavior, and health status.

Who can participate

Age range25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 25 years or older
✓. 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
✓. 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.
✓. 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.
✓. Participant and study partner must be capable of reliably completing study assessments.

What they're measuring

Cognitive Measure

Timeframe: through study completion, an average of 2 years

Functional Measure

Timeframe: through study completion, an average of 2 years

Behavioral Measure

Timeframe: through study completion, an average of 2 years

Health Measures

Timeframe: through study completion, an average of 2 years

Behavioral Measure

Timeframe: through study completion, an average of 2 years

Trial details

NCT IDNCT04149197

SponsorLuMind IDSC Foundation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-04-17

View on ClinicalTrials.gov More Alzheimer's Disease in Down Syndrome trials

Who can participate

Age range25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 25 years or older
✓. 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
✓. 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.
✓. 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.
✓. Participant and study partner must be capable of reliably completing study assessments.

What they're measuring

Cognitive Measure

Timeframe: through study completion, an average of 2 years

Functional Measure

Timeframe: through study completion, an average of 2 years

Behavioral Measure

Timeframe: through study completion, an average of 2 years

Health Measures

Timeframe: through study completion, an average of 2 years

Behavioral Measure

Timeframe: through study completion, an average of 2 years