Natural History of Amyloid Deposition in Adults With Down Syndrome

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to assess the presence of amyloid in non-demented/functionally stable adults with DS as a function of age, dividing the sample into amyloid-positive and amyloid-negative groups. We will also obtain baseline cognitive measures across a range of areas that are often affected by AD.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Down Syndrome Biomarker Initiative (DSBI)

NCT02141971

Down Syndrome Alzheimer's Disease

COMPLETED

Elucidating Age-related Comorbidity Patterns in Down Syndrome (DS)

NCT05310552

Down Syndrome

COMPLETED

Establishing Novel Detection Techniques for Various Genetic-Related Diseases by Applying DHPLC Platform.

NCT00154960

Spinal Muscular Atrophy Neonatal Hyperbilirubinemia Colon Cancer

UNKNOWN

Nutritional Status in Children With Down Syndrome

NCT06989060

Down Syndrome

NOT_YET_RECRUITING

Cervical Spine Abnormalities in Down Syndrome

NCT07260136

Down Syndrome Cervical Spine Instability in Down Syndrome

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Specific Aim 1: To assess and compare amyloid deposition (with PiB PET) in non-demented/functionally stable adults with DS across three age cohorts (30-39, 40-49, and \>50 years of age).

Primary Hypothesis 1: At initial assessment, there will be a significantly higher prevalence of amyloid-positive (PiB+) subjects in each succeeding age cohort.

In addition, we will test the following secondary hypothesis:

Secondary Aim 1: To compare the presence or absence of the apolipoprotein-E4 allele to the retention of PiB in various brain areas of the DS subjects.

Secondary Hypothesis 1: At baseline, subjects who carry at least one Apolipoprotein-E4 (ApoE4) allele will show a higher prevalence of being PiB+.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Down Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adults with Down Syndrome ages 30+ (PiB-/-)

We will be recruiting healthy adults with Down syndrome ages 30 and over. Participants cannot have a diagnosis of dementia.

No interventions assigned to this group

Adults with Down Syndrome ages 30+ (PiB-/+)

No interventions assigned to this group

Adults with Down Syndrome ages 30+ (PiB+/+)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participant IQ at least 47 (based upon Stanford-Binet V Abbrev. Test Battery)
2. Participant at least 30 years of age
3. DSDS score indicating participant is asymptomatic for AD
4. Reliable caregiver who is capable of providing correct information about the participant's clinical symptoms and history
5. Agreement of caregiver and clinician that participant is able to cooperate with the protocol tasks
6. Participant has provided assent (or consent) and/or parent/caregiver has provided informed consent

Exclusion Criteria

1. Participant is non-verbal or has extremely limited language skills
2. Score within the "symptomatic" range on the DSDS
3. Any significant disease or unstable medical condition that could affect neuropsychological testing
4. Any problems with vision or hearing that could affect neuropsychological testing
5. Participants in whom MRI is contraindicated
6. Claustrophobia or prior failed experiences of completing MRI scans or blood draws
7. Participant is pregnant or breast feeding
8. History or other evidence of severe illness or other condition that would make the participant, in the opinion of the investigator, unsuitable for the study?

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes