Donepezil Hydrochloride in Alzheimer Disease: NCT07680660 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 16 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Not Applicable
Clinical phase
Not yet recruiting
Recruitment status
216
Planned enrollment
2028-09-30
Primary-completion proxy
Executive view
NCT07680660 evaluates Donepezil Hydrochloride in Alzheimer Disease. The disclosed sponsor is The Ninth People's Hospital of Shanghai Jiaotong University Medical College, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score at Month 12, assessed over Baseline and Month 12.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07680660 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Alzheimer Disease landscape. Drug & Asset MCP drug_fetch was queried for Donepezil Hydrochloride, while Company & Deal Intelligence MCP organization_fetch was queried for The Ninth People's Hospital of Shanghai Jiaotong University Medical College.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07680660 | Donepezil Hydrochloride | Not Applicable / Not yet recruiting | The Ninth People's Hospital of Shanghai Jiaotong University Medical College | China | Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score at Month 12 Baseline and Month 12 | 2028-09-30 |
| NCT07780383 | PRX-005 | Phase 1 / Not yet recruiting | Bristol Myers Squibb Co. | United States | Absolute bioavailability estimated from geometric mean ratio (GMR) of area under the concentration-time curve from time… Up to approximately 5 months | 2027-06-17 |
| NCT07768592 | E2511 | Phase 1 / Not yet recruiting | Eisai, Inc. | Geography not reported | Part A (Core Trial): Change from Baseline in [11C]MK-6884 Positron Emission Tomography (PET) Using Non-Displaceable Bin… Baseline up to Day 14 | 2030-05-06 |
| NCT07764679 | [18F]Fluorbetazine | Phase 3 / Recruiting | HTA Co., Ltd. | China | The sensitivity and specificity of PET imaging visual interpretation results compared to true standards after a single… 1 year | 2027-12-31 |
| NCT07764146 | VY-1706 | Phase 1 / Recruiting | Voyager Therapeutics, Inc. | United States | To characterize the safety and tolerability in participants with AD by Incidence of treatment emergent adverse events… 52 weeks | 2029-04-28 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07680660 is a Not Applicable, not yet recruiting study with 216 planned participants. Allocation is Randomized, masking is Single, and the intervention model is Parallel Assignment.
The primary endpoint is “Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score at Month 12” over “Baseline and Month 12.” The retrieved endpoint description is: The Clinical Dementia Rating-Sum of Boxes is a clinician-rated measure of dementia severity. The score ranges from 0 to 18, with higher scores indicating greater impairment and more severe dementia. The outcome measure is the change from baseline to Month 12. The scale will be administered face to face by trained evaluators blinded to treatment assignment, and results will be reviewed by an independent endpoint adjudication committee..
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 216 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
The protocol identifies Donepezil Hydrochloride as control therapy. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Alzheimer Disease. These records do not establish direct evidence for NCT07680660 unless the registration number matches.
Randomized, Delayed Start, Double Blind, Parallel Group, Placebo Controlled, Multicenter Study of Piromelatine 20 mg in Participants With Mild Dementia Due to Alzheimer's Disease
Phase 2/3; n=216; Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog 14)(Mean) = -2 ADAS-Cog score (Standard Deviation, 5.20); Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog 14)(Mean) = -1.9 ADAS-Cog score (Standard Deviation, 5.59) Source: https://clinicaltrials.gov/ct2/show/results/NCT05267535
A Multiple Ascending Dose Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to…
Phase 1; n=34; Number of Participants Who Experienced an Adverse Event (AE) = 7 Participants ; Number of Participants Who Experienced an Adverse Event (AE) = 5 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05466422
ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation 2: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatm…
Phase 3; n=408; Cohen-Mansfield Agitation Inventory (CMAI)(Least Squares Mean) = -12.77 score on a scale (Standard Error, 0.921); Cohen-Mansfield Agitation Inventory (CMAI)(Least Squares Mean) = -13.85 score on a scale (Standard Error, 0.917) Source: https://clinicaltrials.gov/ct2/show/results/NCT05557409
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Donepezil Hydrochloride is indexed as Small molecule drug with ACHE biology and a global stage of Approved. The asset profile lists Eisai Co., Ltd. as an originator or developer.
No exact Company & Deal Intelligence profile was returned for The Ninth People's Hospital of Shanghai Jiaotong University Medical College. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Donepezil Hydrochloride is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07680660
Protocol source: https://clinicaltrials.gov/study/NCT07680660
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 16 September 2026.
Donepezil Hydrochloride in Alzheimer Disease is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score at Month 12 and 2028-09-30 the leading decision points.
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