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NCT06850597
Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease
Phase 2 trial testing dimethyl fumarate in MCI in 30 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | Medical University of Lodz |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 28 October 2024 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2027 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- dimethyl fumarate (DIMETHYL FUMARATE) — full drug profile →
Conditions studied
- MCI — all drugs for MCI →
- MCI-AD, Early Stage Alzheimer's Disease — all drugs for MCI-AD, Early Stage Alzheimer's Disease →
- Alzheimer's Disease — all drugs for Alzheimer's Disease →
Sponsor
Medical University of Lodz
Who can join
Adults 55 to 90, any sex, with MCI or MCI-AD, Early Stage Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to assess the degree of improvement in cognitive functions, including memory, attention, thinking, executive and language functions in diagnosed patients MCI and AD taking dimethyl fumarate 480 mg daily compared to patients taking placebo. Participant will be 55 to 90 years old, both genders. The main question it aims to answer is: Changing the degree of cognitive improvement based on the RBANS score among patients diagnosed with MCI and AD after completing dimethyl fumarate therapy test group compared to the placebo group.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dimethyl fumarate as a versatile therapeutic agent: molecular mechanisms and potential clinical applications.
Zingkou E, Medoro A, Davinelli S, Saso L, et al · · 2026 · cited 1× · PMID 41627610 · DOI 10.1007/s11033-026-11478-7 -
The Emerging Role of Dimethyl Fumarate in Alzheimer's Disease-A Systematic Review of Available Preclinical Studies.
Mouaimi M, Metaxas A, Kourti M. · · 2026 · PMID 42196209 · DOI 10.3390/ijms27104227 -
Alzheimer's disease drug development pipeline: 2026.
Cummings JL, Zhou Y, Yang Y, Zhong K, et al · · 2026 · PMID 42095064 · DOI 10.1002/trc2.70251 -
Programmed cell death inhibitors: a new hope for cancer therapy?
Zhong Y, Zhang Y, Cheng L, Chen Q, et al · · 2026 · PMID 41664148 · DOI 10.1186/s12957-026-04241-6 -
Dimethyl Fumarate vs. Monomethyl Fumarate: Unresolved Pharmacologic Issues.
Kopincova J, Bernatova I. · · 2025 · PMID 41471022 · DOI 10.3390/pharmaceutics17121506
Verify or expand the search:
- PubMed search for NCT06850597
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Medical University of Lodz trials
Trials by the same sponsor.
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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 NCT06850597 (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 Medical University of Lodz
- Last refreshed: 27 February 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/NCT06850597.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing