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 range

25 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

25 Years

Sex

ALL

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