Summary
Donepezil Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Alzheimer's Disease and Other Dementias would be drug repurposing rather than first-in-human development. This does not mean it is approved for Alzheimer's Disease and Other Dementias. No registered clinical trial in this database tests Donepezil Hydrochloride specifically in Alzheimer's Disease and Other Dementias. The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study. The literature layer holds 7 publications for this pair: 2 meta-analyses and 5 clinical trial publications. Publication years run from 2022 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Alzheimer's Disease and Other Dementias ranks 705 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Progressive and irreversible by definition; MMSE decline 1.07-3.4 points/year untreated; no spontaneous remission.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 38.0 (trials 0.0, literature 18.0, tier 15, approved bonus 5.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 7 (5 clinical trial publications, 2 meta-analyses) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
No registered trial links Donepezil Hydrochloride to Alzheimer's Disease and Other Dementias in the current OSMF trial extract.
Published literature
- Clinical trial publication Effect of Social Restriction Due to the COVID-19 Pandemic on Activity of Daily Living and Disease Severity of Patients With Alzheimer Disease: Sub-analysis of a Double-blinded Noninferiority Study of Donepezil Patches and Donepezil TabletsNakamura Y, Omori T, Nishiyama K et al. · Alzheimer disease and associated disorders · 2025 · PMID 39886755
- Clinical trial publication Effect of Social Isolation Due to the COVID-19 Pandemic on Cognitive Dysfunction of Patients With Alzheimer Disease: Subanalysis of Double-blinded Noninferiority Study of Donepezil Patches and Donepezil TabletsNakamura Y, Omori T, Nishiyama K et al. · Alzheimer disease and associated disorders · 2024 · PMID 39588690
- Clinical trial publication Clinical observation on treatment of Alzheimer's disease with Sun's scalp-abdominal acupuncture combined with donepezil hydrochlorideZhang SQ, Ma S, Yang TS et al. · Zhen ci yan jiu = Acupuncture research · 2024 · PMID 38764122
- Clinical trial publication Effects of pressing moxibustion at Baihui (GV 20) and Guanyuan (CV 4) on cognitive impairment and serum levels of Aβ(1-42), tau, P-tau in patients with mild to moderate Alzheimer's diseaseYang S, Fan D, Su S et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2024 · PMID 38467498
- Clinical trial publication Effect of acupuncture at the acupoints for Yizhi Tiaoshen on the functional connectivity between the hippocampus and the brain in the patients with Alzheimer's diseaseWei YT, Su ML, Zhu TT et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2023 · PMID 38092531
- Meta-analysis The role of tonifying kidney decoction and acupuncture in the treatment of Alzheimer's disease: A network meta-analysisWang XC, Chu CL, Lu K et al. · Medicine · 2022 · PMID 36401402
- Meta-analysis A systematic review of the efficacy of donepezil hydrochloride combined with nimodipine on treating vascular dementiaYang Q, Liu J, Huang KL et al. · Medicine · 2022 · PMID 35945739
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Donepezil Hydrochloride approved for Alzheimer's Disease and Other Dementias?
Donepezil Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Alzheimer's Disease and Other Dementias would be drug repurposing rather than first-in-human development. This does not mean it is approved for Alzheimer's Disease and Other Dementias. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Donepezil Hydrochloride in clinical trials for Alzheimer's Disease and Other Dementias?
No registered clinical trial in this database tests Donepezil Hydrochloride specifically in Alzheimer's Disease and Other Dementias. The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study.
What does the evidence show for Donepezil Hydrochloride in Alzheimer's Disease and Other Dementias?
Synthesis-level literature links Donepezil Hydrochloride to Alzheimer's Disease and Other Dementias, but no registered trial in this database tests the pair, so the evidence is observational, pooled from other indications, or pre-dates registry practice. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.