Alzheimer's Disease Research Cohort for Down Syndrome

(TRC-DS Trial)

Recruiting at 31 trial locations

Overseen By ATRI Recruitment Team

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: Anticoagulants

Disqualifiers: Unstable psychiatric, cardiac, renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about Alzheimer's in adults with Down syndrome (DS) by examining their cognitive abilities and various health markers. Researchers seek to understand the connection between cognitive changes and Alzheimer's indicators to better track the disease's progress. The trial seeks adults with DS, aged 25-55, who are in good health and have not been diagnosed with dementia. Participants will undergo cognitive testing, health assessments, and imaging to aid in developing future clinical trials for Alzheimer's in DS. The study will investigate treatments known as ABC-DS and TRC-DS for their potential benefits in this context. As an unphased trial, this study offers participants the chance to contribute to foundational research that could lead to significant advancements in Alzheimer's treatment for individuals with Down syndrome.

Do I need to stop my current medications to join the trial?

The trial allows participants to continue taking certain medications that affect the central nervous system, as long as the dose has been stable for at least 4 weeks. If you start new medications, the medical team will review your case to decide the timing of your cognitive testing.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the ABC-DS and TRC-DS studies aim to gather information and biological markers related to Alzheimer's in adults with Down syndrome. These observational studies involve regular check-ups, tests, and scans. Participants have engaged in these activities for several years without reports of harmful effects, suggesting that the procedures are safe and well-tolerated.

Since 2015, over 500 adults with Down syndrome have participated in the ABC-DS study. Nearly 350 have returned for follow-up visits, indicating that participants find the study manageable and safe. This ongoing participation highlights the strong safety record of the procedures used in these studies.

Overall, the information collected helps researchers better understand Alzheimer's disease in people with Down syndrome. The focus on observing and gathering data is generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TRC-DS trial because it aims to create a cohort of non-demented adults with Down syndrome to better understand Alzheimer's disease progression and treatment responses in this population. Unlike standard treatments for Alzheimer's, which typically focus on symptom management, this trial is unique in its focus on a specific group—adults with Down syndrome—who are at higher risk for developing Alzheimer's. By studying this group, researchers hope to uncover insights into disease mechanisms and tailor future therapies more effectively for Down syndrome patients. This approach could lead to breakthroughs in personalized medicine for those with Down syndrome, offering new hope for early intervention and improved outcomes.

What evidence suggests that this trial's treatments could be effective for Down syndrome?

Research has shown a strong connection between Down syndrome (DS) and Alzheimer's disease (AD). The Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) study seeks to identify biomarkers, which are bodily indicators of a condition, for Alzheimer's in adults with Down syndrome. This research aims to understand Alzheimer's development in people with DS, which is crucial for creating effective treatments. Data from these studies help determine whether the disease develops similarly in people with Down syndrome and the general population. By studying these biomarkers, researchers aim to discover new methods to track and treat Alzheimer's in those with Down syndrome. ^{1 6 7 8 9}

Who Is on the Research Team?

Michael Rafii, MD, PhD

Principal Investigator

USC Alzheimer's Therapeutic Research Institute (ATRI)

Are You a Good Fit for This Trial?

Inclusion Criteria

Diagnosis of DS (including trisomy 21, mosaic trisomy 21, Robertsonian translocation trisomy 21 or partial trisomy 21) (as confirmed by Karyotype genetic testing or medical record review)

Provision of signed and dated informed consent form; this includes adults with DS who can provide consent, or for whom an LAR provides consent on behalf of the individual to participate. Adults with DS who cannot consent must sign and date an assent accompanied with a signed and dated consent by legally authorized representative (LAR).

Male or female, aged 25-55 inclusive

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline cognitive and clinical assessments, genetic and biomarker testing, as well as imaging and biospecimen collection

4 weeks

Longitudinal Assessment

Participants undergo longitudinal cognitive and clinical assessments to analyze relationships between cognitive measures and biomarkers of Alzheimer's disease

32 months

Follow-up

Participants are monitored for safety and effectiveness after the main assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABC-DS
• TRC-DS

How Is the Trial Designed?

Group I: Trial Ready Cohort Experimental Treatment 3 Interventions

Non-demented adults with Down syndrome (DS)

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Alzheimer's Therapeutic Research Institute

Collaborator

Trials

18

Recruited

58,400+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Alzheimer's Clinical Trials Consortium

Collaborator

Trials

5

Recruited

2,800+

Citations

1. nia.nih.gov nia.nih.gov/research/abc-ds

Alzheimer Biomarkers Consortium — Down Syndrome (ABC ... The ABC-DS is a multidisciplinary, multisite longitudinal study examining biomarkers of DS-AD in a large cohort of adults with DS, ages 25 and older.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04165109

Trial-Ready Cohort-Down Syndrome (TRC-DS) The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ...

3. includedcc.org includedcc.org/studies/alzheimer-biomarker-consortium-down-syndrome-abc-ds

Alzheimer Biomarker Consortium - Down Syndrome (ABC ... Data generated from ABC-DS are necessary to determine if the AD pathological cascade is the same between DS and late onset AD (LOAD) or whether the pathogenic ...

4. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/b1f6761bdfbfed01fbda1a3b518e86bc/Down-syndrome-and-Alzheimer-s-disease.pdf

Down syndrome and Alzheimer's disease ABC-DS is longitudinal study examining biomarkers of AD in adults with Down syndrome (ages 25 and older). • The goal of ABC-DS is to understand.

5. academic.oup.com academic.oup.com/braincomms/article/7/6/fcaf406/8287151

A comparison of multiple amyloid PET radiotracers for Down ... Historically, ABC-DS published amyloid imaging findings using PiB PET, and this new data provides comparisons of PiB PET to FBP, NAV and FMM ...

6. abc-ds.org abc-ds.org/

Homepage - ABC-DS - Staging ABC-DS is a 5-year research project where we follow a group of adult volunteers with Down syndrome to find signs and risks of Alzheimer's.

7. ida.loni.usc.edu ida.loni.usc.edu/collaboration/access/appApply.jsp?project=ABCDS

ABCDS Data Use Agreement The preparation of this manuscript was made possible from data obtained by the Alzheimer's Biomarkers Consortium –Down Syndrome (ABC-DS), a longitudinal study ...

8. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.70294?af=R

The Alzheimer's Biomarker Consortium–Down Syndrome ... Over 500 DS adults with DS and 59 sibling controls have enrolled in ABC-DS since 2015. Almost 350 enrollees with DS have returned for at least one follow-up ...

9. alzheimers.gov alzheimers.gov/clinical-trials/alzheimers-biomarkers-consortium-down-syndrome

Alzheimer's Biomarkers Consortium-Down Syndrome The Alzheimer's Biomarkers Consortium-Down Syndrome (ABC-DS) project is a large research initiative to find biomarkers to track Alzheimer's disease in people ...