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STDMMAD
CompletedPhase 4Results postedSafety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease
Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease: A Multi-center Single-arm Study in China
Lead sponsor
Asset
Donepezil
Listed sites
1
Recruiting sites
-
Enrollment
241
actual
Study population
Alzheimer’s disease
Key I/E criteria
•mild-to-moderate AD•MMSE 10-24•Study partner/caregiver required
Primary endpoint
•Adverse Events (AEs)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Patients between 50 and 85 years of age.
2. Patients newly diagnosed as probable AD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and National Institute of Neurologic and Communicative Disorders and Stroke-AD and Related Disorders Association (NINCDS-ADRDA) criteria; Mild to moderate AD with Mini-Mental State Examination (MMSE) 10-24, modified Hachinski ischaemic scale (MHIS)≤4, Activity of daily life scale (ADL)≥23, and Hamilton Depression Scale (HAMD) <7.
3. MRI image supports the diagnosis of AD (medial temporal lobe atrophy, Fazekas scale of white matter lesions≤2 within 6 months prior to the screening).
4. 5mg daily of Donepezil for at least four weeks before the screening.
5. Patient with exclusive caregiver.
6. Patient should be ambulatory or ambulatory aided by a walker or cane.
7. With good eyesight and hearing, can cooperate with the examination and treatment
Exclusion criteria
1. Patients with vascular dementia, other types of dementia or with other psychiatric or neurological disorders (e.g. delirium, depression, Parkinson's disease, etc.).
2. Patients with type I diabetes, obstructive lung disease or asthma, vitamin B12 or folic acid deficiency, thyroid dysfunction, severe liver or kidney dysfunction, severe cardiac insufficiency (congestive heart failure, myocardial infarction, sick sinus syndrome, II-III degree atrioventricular block or heart rate<50 beats/minute [bpm]).
3. Epilepsy or head trauma resulting in unconsciousness that occurred in the two years prior to the screening.
4. Patients with hematologic diseases (such as anemia, granulocytes, leukemia, etc.), tumor, neoplasms within 2 years prior to the screening.
5. Patients with a history of alcohol dependence and drug abuse.
6. Patients with known hypersensitivity to medicines or foods;
7. Patients taking anticholinergic agents or antihistaminic agents;
8. Patients who had been hospitalized continuously for more than 3 months before the screening.
Endpoints (12)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
2 endpointsChanges in Mini-Mental State Examination Scores From Baseline
Time frame:Baseline, 4, 20 weeks
Mini-Mental State Examination (MMSE)
descriptive
Changes in Mini-Mental State Examination Scores From Baseline
Time frame:Baseline, 4, 20 weeks
Mini-Mental State Examination (MMSE)
descriptive
Posted result
| Group | Value (mean), score on a scale | Standard deviation |
|---|---|---|
| BaselineFAS LOCFn=241 Participants | 18.69 | 4.35 |
| FAS (actual data)n=238 Participants | 18.69 | 4.35 |
| PPS LOCFn=93 Participants | 18.45 | 4.39 |
| PPS (actual data)n=148 Participants | 18.45 | 4.39 |
| Week 4FAS LOCFn=241 Participants | 19.12 | 5.06 |
| FAS (actual data)n=145 Participants | 18.87 | 5.76 |
| PPS LOCFn=93 Participants | 19.22 | 5.18 |
| PPS (actual data)n=113 Participants | 19.33 | 5.53 |
| Change From Baseline at Week 4FAS LOCFn=241 Participants | 0.44 | 2.51 |
| FAS (actual data)n=145 Participants | 0.72 | 3.19 |
| PPS LOCFn=93 Participants | 0.77 | 2.53 |
| PPS (actual data)n=113 Participants | 1.01 | 2.86 |
| Week 20FAS LOCFn=241 Participants | 19.07 | 5.30 |
| FAS (actual data)n=94 Participants | 19.62 | 5.8 |
| PPS LOCFn=93 Participants | 19.11 | 5.54 |
| PPS (actual data)n=93 Participants | 19.57 | 5.81 |
| Change From Baseline at Week 20FAS LOCFn=241 Participants | 0.39 | 2.64 |
| FAS (actual data)n=94 Participants | 0.97 | 3.18 |
| PPS LOCFn=93 Participants | 0.66 | 2.74 |
| PPS (actual data)n=93 Participants | 0.94 | 3.18 |
Function / daily living
2 endpointsChanges in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores From Baseline
Time frame:Baseline, 4, 20 weeks
ADCS-Activities of Daily Living (ADCS-ADL)
descriptive
Changes in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores From Baseline
Time frame:Baseline, 4, 20 weeks
ADCS-Activities of Daily Living (ADCS-ADL)
descriptive
Posted result
| Group | Value (mean), score on a scale | Standard deviation |
|---|---|---|
| BaselineFAS LOCFn=241 Participants | 53.29 | 11.55 |
| FAS (actual data)n=42 Participants | 34.76 | 14.04 |
| PPS LOCFn=93 Participants | 54.31 | 10.63 |
| PPS (actual data)n=26 Participants | 33.31 | 13.58 |
| Week 4FAS LOCFn=241 Participants | 53.71 | 12.97 |
| FAS (actual data)n=42 Participants | 33.31 | 13.75 |
| PPS LOCFn=93 Participants | 54.35 | 12.50 |
| PPS (actual data)n=26 Participants | 32.71 | 13.5 |
| Change From Baseline at Week 4FAS LOCFn=241 Participants | 0.43 | 7.34 |
| FAS (actual data)n=42 Participants | -0.66 | 6.04 |
| PPS LOCFn=93 Participants | 0.04 | 6.20 |
| PPS (actual data)n=26 Participants | -0.65 | 6.69 |
| Week 20FAS LOCFn=241 Participants | 53.62 | 12.82 |
| FAS (actual data)n=42 Participants | 30.86 | 11.01 |
| PPS LOCFn=93 Participants | 54.19 | 12.25 |
| PPS (actual data)n=26 Participants | 30.9 | 11.07 |
| Change From Baseline at Week 20FAS LOCFn=241 Participants | 0.33 | 7.47 |
| FAS (actual data)n=42 Participants | -1.15 | 11.04 |
| PPS LOCFn=93 Participants | -0.12 | 6.44 |
| PPS (actual data)n=26 Participants | -1.13 | 11.11 |
Safety / tolerability / PK
6 endpointsNumber of Patients With Adverse Events (AEs)
Time frame:20 weeks
event count, event
Number of Patients With Adverse Events (AEs)
Time frame:20 weeks
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Donepeziln=241 Participants | 93 | - |
Number of Patients Who Withdrew From the Trial Due to Adverse Events.
Time frame:20 weeks
event count, event
Correlation Between Apolipoprotein E.(APOE) Genotype and Incidence of Adverse Events of Donepezil
Time frame:20 weeks
event count, event
Number of Patients Who Withdrew From the Trial Due to Adverse Events.
Time frame:20 weeks
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Donepeziln=241 Participants | 42 | - |
Correlation Between Apolipoprotein E.(APOE) Genotype and Incidence of Adverse Events of Donepezil
Time frame:20 weeks
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| APOE ɛ2/ɛ2 CarriersNumbe of patients who experienced adverse eventsn=1 Participants | 0 | - |
| Number of patients who did not experience adverse eventsn=1 Participants | 1 | - |
| APOE ɛ3/ɛ3 CarriersNumbe of patients who experienced adverse eventsn=58 Participants | 34 | - |
| Number of patients who did not experience adverse eventsn=58 Participants | 24 | - |
| APOE ɛ4/ɛ4 CarriersNumbe of patients who experienced adverse eventsn=7 Participants | 5 | - |
| Number of patients who did not experience adverse eventsn=7 Participants | 2 | - |
| APOE ɛ2/ɛ3 CarriersNumbe of patients who experienced adverse eventsn=11 Participants | 6 | - |
| Number of patients who did not experience adverse eventsn=11 Participants | 5 | - |
| APOE ɛ2/ɛ4 CarriersNumbe of patients who experienced adverse eventsn=1 Participants | 0 | - |
| Number of patients who did not experience adverse eventsn=1 Participants | 1 | - |
| APOE ɛ3/e4 CarriersNumbe of patients who experienced adverse eventsn=37 Participants | 13 | - |
| Number of patients who did not experience adverse eventsn=37 Participants | 24 | - |
Age (\>75y vs ≤75y）
APOE ɛ4 (carrier vs non-carrier)
Concomitant medication：Gastrointestinal drugs
Concomitant medication：Hypoglycemic drugs
Concomitant medication：Cardiovascular and Cerebrovascular drugs
Concomitant medication：Hepatology drugs
Duration of previous donepezil 5mg/d therapy (day)
Other (unclassified)
2 endpointsAPOE Genotype
Time frame:4 weeks
descriptive
APOE Genotype
Time frame:4 weeks
descriptive
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| DonepezilAPOE ɛ2/ɛ2n=115 Participants | 1 | - |
| APOE ɛ3/ɛ3n=115 Participants | 58 | - |
| APOE ɛ4/ɛ4n=115 Participants | 7 | - |
| APOE ɛ2/ɛ3n=115 Participants | 11 | - |
| APOE ɛ2/ɛ4n=115 Participants | 1 | - |
| APOE ɛ3/e4n=115 Participants | 37 | - |
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID31985467via DERIVED
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.