CompletedNot Applicable

Relationship Between Down Syndrome (DS) and Alzheimer's Disease (AD)

United States19 participantsStarted 2016-11

Plain-language summary

In order to treat individuals with Down syndrome (DS) better and more efficiently and to gain more insights on its relation to Alzheimer's disease (AD), a comprehensive understanding is needed for its progression in the early or preclinical phase using various biomarkers. DS is a significant risk factor for the early development of AD, with plaques and tangles typically developing by age 35. A better understanding is needed of early markers of the disease in DS patients. Additionally the DS population represents a unique group - due to this elevated risk for AD - to examine biomarkers that may translate in general outside of the DS population to individuals at risk for developing late onset AD. In this proposal, the researchers will assess the longitudinal changes of various biomarkers in a cohort of individuals similar in design to the cross-sectional sectional study in the preliminary data.

Who can participate

Age range21 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 for Non-AD/DS subjects: * Subjects with free Trisomy 21. * Male or female subjects who are 21 years of age or older. * Subjects who are not diagnosed with possible or probable AD or dementia after evaluation NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke- Alzheimer's Disease and Related Disorders Association) criteria. * Subjects who live with or have regular visits from a responsible caregiver willing to provide information about the subject's cognitive status. * If the subject is incapable of giving informed consent, the caregiver may consent on behalf of the subject (subject must still confirm assent). Inclusion criteria for AD/DS subjects: * Subjects with free Trisomy 21. * Male or female subjects who are 40 and older years of age. * Subjects who are diagnosed with possible or probable using NINCDS-ADRDA criteria. * Subjects who live with or have regular visits from a responsible caregiver willing to provide information about the subject's cognitive status. * If the subject is incapable of giving informed consent, the caregiver may consent on behalf of the subject (subject must still confirm assent). Inclusion criteria for Normal Controls * Cognitively normal, non-DS individuals. * Age-matched to the DS group. * Subjects who signed an Institutional Review Board-approved informed consent. Exclusion Criteria: (for all groups) * Previous or current diagnosis of a neurodegenerative disorders other than AD or D…

What they're measuring

Florbetapir PET - change between timeframes

Timeframe: Year 1, Year 2-3

tau PET - change between timeframes

Timeframe: Year 1, Year 2-3

FDG PET - change between timeframes

Timeframe: Year 1, Year 2-3

MRI - change between timeframes

Timeframe: Year 1, Year 2-3

Trial details

NCT IDNCT02759887

SponsorSt. Joseph's Hospital and Medical Center, Phoenix

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

View on ClinicalTrials.gov More Down Syndrome trials

Plain-language summary

Who can participate

Age range21 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.