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NCT06860373
LIFE-DSR-Biomarker Sub-study of Biomarkers in Down Syndrome Related Alzheimer's Disease (DS-AD)
Phase 3 trial testing [18F]MK-6240 in Down Syndrome in 5 participants. Terminated before completion.
17 April 2024
Quick facts
| Lead sponsor | LuMind IDSC Foundation |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 5 |
| Start date | 27 June 2023 |
| Primary completion | 17 April 2024 |
| Estimated completion | 17 April 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- [18F]MK-6240 — full drug profile →
Conditions studied
- Down Syndrome — all drugs for Down Syndrome →
Sponsor
LuMind IDSC Foundation
Who can join
Adults 35 to 55, any sex, with Down Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06860373
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of [18F]MK-6240
Trials testing the same drug.
- NCT04566003 — Evaluation Comparing Tau PET Radiotracers, [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in Subjects With Normal Cognition · Phase 1 · completed
Other recruiting trials for Down Syndrome
Currently open trials in the same condition.
- NCT07416201 — Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy · recruiting
- NCT07484464 — Effects of the Otago Exercise Program on Balance, Endurance, and Motor Coordination in Children With Down Syndrome · NA · recruiting
- NCT07428863 — Effects of Jump Rope on Navicular Drop in Down Syndrome · NA · recruiting
- NCT07260136 — Cervical Spine Abnormalities in Down Syndrome · active not recruiting
- NCT07248449 — Physical Fitness in DS: A Comparison of Cuevas Medak and Rebound Exercises · NA · recruiting
Other LuMind IDSC Foundation trials
Trials by the same sponsor.
- NCT06484426 — Goal Attainment Scaling (GAS) Sub-Study · completed
- NCT04149197 — Down Syndrome Clinical Trials - Study of Alzheimer's Disease in Down Syndrome · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06860373 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by LuMind IDSC Foundation
- Last refreshed: 6 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06860373.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing