LIFE-DSR-Biomarker Sub-study of Biomarkers in Down Syndrome Related Alzheimer's Disease (DS-AD) (NCT06860373) | Clinical Trial Compass
TerminatedPhase 3
LIFE-DSR-Biomarker Sub-study of Biomarkers in Down Syndrome Related Alzheimer's Disease (DS-AD)
Stopped: Unable to recruit
United States5 participantsStarted 2023-06-27
Plain-language summary
This is an optional sub-study that will enroll participants from the LIFE-DSR parent protocol. Participants will undergo assessments at two timepoints, including: additional blood samples for PBMC and RNA extraction, as well as a lumbar puncture for collection of CSF, and/or MRI and tau PET imaging. Sub-study visits will be scheduled around a similar calendar-day as the parent protocol study visits (e.g., Month (M) 0 (M0) and M16, or M16 and M32).
Who can participate
Age range35 Years – 55 Years
SexALL
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Inclusion criteria
✓. The participant must be currently enrolled in the LIFE-DSR parent protocol.
✓. The adult with DS must be age 35 to 55 years.
✓. Both the participant, or LAR, and their caregiver must be able to understand and be willing to provide consent. The LAR will sign the informed consent. The participant will sign the informed consent or assent.
✓. Both the participant, or LAR, and their caregiver must be willing to comply with the scheduled visits and scheduled assessments.
✓. Agreement of caregiver and clinician the participant can cooperate with protocol tasks.
Exclusion criteria
✕. Assessment (per medical history, physical exam, vital signs or other clinically relevant measure or circumstance) which, in the opinion of the site PI, makes the participant unsuitable for participation in this study.
✕. Evidence for raised intracranial pressure. Examples include papilledema on physical exam or CNS lesion with mass effect.
✕. Presence of lower spinal malformations, prior lumbosacral spinal surgery, local infection, or other abnormalities that would exclude lumbar puncture.
What they're measuring
1
Primary Outcome Measure to establish a biobank specifically for DS participants
Timeframe: Month 0 and Month 16 or Month 16 and Month 32
2
Primary Outcome to ascertain the degree and distribution of tau pathology in DS as a function of age using tau PET
Timeframe: Month 0 and Month 16 or Month 16 and Month 32
✕. Allergy to Lidocaine (xylocaine) or its derivatives.
✕. Evidence or history of significant active bleeding or coagulation disorder, or use of anticoagulant medications such as coumadin, heparin, thrombin inhibitors (e.g., dabigatran) or factor Xa inhibitors (e.g., apixaban).
✕. Previous or ongoing treatment with aducanumab (AduhelmTM) OR any anti-amyloid OR any anti-tau antibody OR investigational treatment within the previous 30-calendar days of this sub-study baseline LP. Treatment with AduhelmTM is permitted in the LIFE-DSR parent protocol but precludes participation in this LP sub-study.
✕. Contraindication to MRI or PET scans, evidenced by presence or history of any significant or uncontrolled medical condition which, in the opinion of the Investigator, would increase the potential risk to the study participant (e.g., history of CNS infection, history of exposure to CNS toxin, epilepsy, sensitivity to flashing lights, pacemaker).
✕. Participants in whom 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.