Last reviewed · How we verify
NCT04263519
A Pilot Open Labeled Study of Tacrolimus in Alzheimer's Disease.
Phase 2 trial testing Tacrolimus in Alzheimer Disease. Withdrawn.
1 December 2022
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 December 2021 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 January 2023 |
Drugs / interventions tested
- Tacrolimus (TACROLIMUS) — full drug profile →
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
- Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
Sponsor
Massachusetts General Hospital
Who can join
Adults 55 to 85, any sex, with Alzheimer Disease or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Pilot open labeled study of Tacrolimus in Alzheimer's Disease.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Alzheimer's disease drug development pipeline: 2020.
Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2020 · cited 350× · PMID 32695874 · DOI 10.1002/trc2.12050 -
Alzheimer's disease drug development pipeline: 2021.
Cummings J, Lee G, Zhong K, Fonseca J, et al · · 2021 · cited 312× · PMID 34095440 · DOI 10.1002/trc2.12179 -
Pathological mechanisms and therapeutic strategies for Alzheimer's disease.
Ju Y, Tam KY. · · 2022 · cited 260× · PMID 34380884 · DOI 10.4103/1673-5374.320970 -
Amelioration of Alzheimer's disease pathology by mitophagy inducers identified via machine learning and a cross-species workflow.
Xie C, Zhuang XX, Niu Z, Ai R, et al · · 2022 · cited 255× · PMID 34992270 · DOI 10.1038/s41551-021-00819-5 -
Glial Cell-Mediated Neuroinflammation in Alzheimer's Disease.
Al-Ghraiybah NF, Wang J, Alkhalifa AE, Roberts AB, et al · · 2022 · cited 127× · PMID 36142483 · DOI 10.3390/ijms231810572 -
Repurposed agents in the Alzheimer's disease drug development pipeline.
Bauzon J, Lee G, Cummings J. · · 2020 · cited 46× · PMID 32807237 · DOI 10.1186/s13195-020-00662-x -
Repositioning of Immunomodulators: A Ray of Hope for Alzheimer's Disease?
Munafò A, Burgaletto C, Di Benedetto G, Di Mauro M, et al · · 2020 · cited 27× · PMID 33343293 · DOI 10.3389/fnins.2020.614643 -
Pin1 and Alzheimer's disease.
Malter JS. · · 2023 · cited 15× · PMID 36162703 · DOI 10.1016/j.trsl.2022.09.003
Verify or expand the search:
- PubMed search for NCT04263519
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tacrolimus
Trials testing the same drug.
- NCT07519174 — A Randomized Controlled Trial Comparing the Effectiveness and Safety of Topical Tacrolimus 0.03% Versus Crisaborole 2% i · NA · not yet recruiting
- NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease ( · Phase 2 · recruiting
- NCT07349771 — Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoie · Phase 2 · not yet recruiting
- NCT06996119 — Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versu · Phase 1 · not yet recruiting
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
Other recruiting trials for Alzheimer Disease
Currently open trials in the same condition.
- NCT07290387 — Tele-Savvy for Latino Caregivers · NA · recruiting
- NCT07178210 — Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease · NA · recruiting
- NCT07294885 — Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease · NA · recruiting
- NCT06937229 — A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) · Phase 3 · recruiting
- NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms · NA · recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
- NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
- NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
- NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
- NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
- NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting
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 NCT04263519 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
- Last refreshed: 27 September 2021
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/NCT04263519.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing