Clinical trial NCT04149197: Down Syndrome Clinical Trials - Study of Alzheimer's Disease in Down Syndrome
Official title: The Down Syndrome Clinical Trials Network (DS-CTN) Study of Alzheimer's Disease in Down Syndrome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alzheimer's Disease in Down Syndrome
Keywords: Down Syndrome
Alzheimer's Disease
Lead sponsor: LuMind IDSC Foundation
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 252
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males and females, aged 25 and older, with a diagnosis of DS, typically supported by karyotype analysis documenting full trisomy for chromosome 21 or complete unbalanced translocation of chromosome 21.

Brief 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.

Detailed description: The DS-CTN will engage in rigorous, high quality research to better understand AD-DS and the medical needs of this population. The LIFE-DSR study will utilize the DS-CTN network to achieve these goals through evidence-based research and a combination of proven and novel methodologies. The network will initially recruit and employ experts and clinical trial sites who have access to adults with DS and whose focus is on AD-DS.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 25 years or older
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.

Exclusion Criteria Participants and study partners who, in the opinion of the site PI, are not able to complete trial procedures or adhere to the schedule of study assessments will be excluded from study participation.

Primary outcomes:
measure: Cognitive Measure
timeFrame: through study completion, an average of 2 years
measure: Functional Measure
timeFrame: through study completion, an average of 2 years
measure: Behavioral Measure
timeFrame: through study completion, an average of 2 years
measure: Health Measures
timeFrame: through study completion, an average of 2 years
measure: Behavioral Measure
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Exploratory Outcome Measure Preliminary composite measure from the scales being used in LIFE-DSR
timeFrame: through study completion, an average of 2 years
measure: Exploratory Outcome Measure Novel multi-domain instrument for AD-DS development
timeFrame: through study completion, an average of 2 years
measure: Exploratory Outcome Measure Potential Screening Measures
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Irvine
country: United States
facility: University California Irvine
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Health
state: Illinois
city: Fairway
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Lexington
country: United States
facility: University Of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: LuMind IDSC Foundation
name: Lois Kelly
role: STUDY_DIRECTOR
References: