RECRUITING

Trial-Ready Cohort-Down Syndrome (TRC-DS)

Conditions

Down Syndrome Alzheimer Disease Dementia Trial-Ready Cohort Observational Alzheimer's Prevention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 ready cohort (TRC), and up to 450 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/.

Official Title

Alzheimer's Clinical Trial Consortium for Down Syndrome (ACTC-DS) Trial-Ready Cohort - Down Syndrome (TRC-DS)

Quick Facts

Study Start:2021-06-07

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04165109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. 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) 2. 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). 3. Stated availability and willingness to comply with all study procedures and availability for the duration of the study or until referred to a clinical trial 4. Male or female, aged 25-55 inclusive 5. In good general health as evidenced by medical history with no diagnosis of dementia 6. Permitted CNS-active medications, stable in dose for at least 4 weeks or longer. If new medications have been started, medical monitoring team will review on case by case basis to recommend timing of baseline cognitive testing 7. Adequate visual and auditory acuity to allow neuropsychological testing 8. Mental Age of 4 years or greater (based upon the Kaufman Brief Intelligence Test, Second Edition, or based upon medical records) 9. IQ equal to or greater than 40 (based upon the Kaufman Brief Intelligence Test, Second Edition) 10. Must speak English or Spanish fluently 11. Must have a reliable Study Partner (may be caregiver, sibling, parent) who is capable of providing correct information about the participant's clinical symptoms and history	1. Any significant disease or unstable medical condition that could affect participation (i.e., unstable psychiatric disease, unstable cardiac problems, chronic renal failure, chronic hepatic disease, severe pulmonary disease) 2. Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant (Dental fillings do not present a risk for MRI) 3. Participants unable to complete MRI procedure 4. History, within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment 5. Clinically significant abnormalities in B12 or TFTs that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant. A high TSH is exclusionary unless follow up T3/T4 levels indicate that it is not physiologically significant. 6. Clinically significant abnormalities in screening laboratories 7. For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation therapy (e.g. warfarin) 8. Concurrent participation in a clinical trial for an investigational product or concurrent participation in longitudinal study with overlapping outcome measures/procedures is prohibited with the exception of ABC-DS co-enrollment or as approved by project director 9. Participants whom the investigator deems to be otherwise ineligible. The Investigators should consult with the Coordinating Center on any issues that may disqualify the participant from participation in future clinical trials to determine whether enrollment into TRC-DS would be appropriate

Inclusion Criteria

Exclusion Criteria

1. 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)
2. 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).
3. Stated availability and willingness to comply with all study procedures and availability for the duration of the study or until referred to a clinical trial
4. Male or female, aged 25-55 inclusive
5. In good general health as evidenced by medical history with no diagnosis of dementia
6. Permitted CNS-active medications, stable in dose for at least 4 weeks or longer. If new medications have been started, medical monitoring team will review on case by case basis to recommend timing of baseline cognitive testing
7. Adequate visual and auditory acuity to allow neuropsychological testing
8. Mental Age of 4 years or greater (based upon the Kaufman Brief Intelligence Test, Second Edition, or based upon medical records)
9. IQ equal to or greater than 40 (based upon the Kaufman Brief Intelligence Test, Second Edition)
10. Must speak English or Spanish fluently
11. Must have a reliable Study Partner (may be caregiver, sibling, parent) who is capable of providing correct information about the participant's clinical symptoms and history

1. Any significant disease or unstable medical condition that could affect participation (i.e., unstable psychiatric disease, unstable cardiac problems, chronic renal failure, chronic hepatic disease, severe pulmonary disease)
2. Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant (Dental fillings do not present a risk for MRI)
3. Participants unable to complete MRI procedure
4. History, within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
5. Clinically significant abnormalities in B12 or TFTs that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant. A high TSH is exclusionary unless follow up T3/T4 levels indicate that it is not physiologically significant.
6. Clinically significant abnormalities in screening laboratories
7. For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation therapy (e.g. warfarin)
8. Concurrent participation in a clinical trial for an investigational product or concurrent participation in longitudinal study with overlapping outcome measures/procedures is prohibited with the exception of ABC-DS co-enrollment or as approved by project director
9. Participants whom the investigator deems to be otherwise ineligible. The Investigators should consult with the Coordinating Center on any issues that may disqualify the participant from participation in future clinical trials to determine whether enrollment into TRC-DS would be appropriate

Contacts and Locations

Study Contact

ATRI Recruitment Team

CONTACT

213-821-0569

atri-recruit@usc.edu

Principal Investigator

Michael Rafii, MD, PhD

PRINCIPAL_INVESTIGATOR

USC Alzheimer's Therapeutic Research Institute (ATRI)

Study Locations (Sites)

Barrow Neurological Institute

Phoenix, Arizona, 85013

United States

University of California, Irvine School of Medicine, Co-Enrolling through ABC-DS Only

Orange, California, 92868

United States

Linda Crnic Institute for Down Syndrome, University of Colorado

Aurora, Colorado, 80045

United States

Indiana University

Indianapolis, Indiana, 46202

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

University of Kentucky, Co-Enrolling through ABC-DS Only

Lexington, Kentucky, 40504

United States

Massachusetts General Hospital, Co-Enrolling through ABC-DS Only

Boston, Massachusetts, 02114

United States

Washington University, St. Louis

Saint Louis, Missouri, 63108

United States

New York State Institute for Basic Research in Developmental Disabilities (SIBRDD), Co-Enrolling through ABC-DS Only

Staten Island, New York, 10314

United States

Case Western Reserve University

Beachwood, Ohio, 44122

United States

University of Pittsburgh, Co-Enrolling through ABC-DS Only

Pittsburgh, Pennsylvania, 15213

United States

Vanderbilt University Medical Center Center for Cognitive Medicine

Nashville, Tennessee, 37212

United States

University of Texas Health San Antonio, Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases

San Antonio, Texas, 78229

United States

University of Wisconsin - Madison, Waisman Center, Co-Enrolling through ABC-DS Only

Madison, Wisconsin, 53705

United States

Collaborators and Investigators

Sponsor: University of Southern California

Michael Rafii, MD, PhD, PRINCIPAL_INVESTIGATOR, USC Alzheimer's Therapeutic Research Institute (ATRI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-07

Study Completion Date2025-12

Study Record Updates

Study Start Date2021-06-07

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Trial-Ready Cohort
Observational
Alzheimer's
Prevention
Down Syndrome

Additional Relevant MeSH Terms

Down Syndrome
Alzheimer Disease
Dementia