Alzheimer's DiseasePhase 4STDMMADNCT02787746
Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease
A Phase 4 study testing Donepezil in people with Alzheimer's Disease, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in China. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Donepezil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Mar 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 50 and 85 years of age.
- 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.
- 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).
- 5mg daily of Donepezil for at least four weeks before the screening.
- Patient with exclusive caregiver.
- Patient should be ambulatory or ambulatory aided by a walker or cane.
- With good eyesight and hearing, can cooperate with the examination and treatment.
Who cannot join
- Patients with vascular dementia, other types of dementia or with other psychiatric or neurological disorders (e.g. delirium, depression, Parkinson's disease, etc.).
- 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]).
- Epilepsy or head trauma resulting in unconsciousness that occurred in the two years prior to the screening.
- Patients with hematologic diseases (such as anemia, granulocytes, leukemia, etc.), tumor, neoplasms within 2 years prior to the screening.
- Patients with a history of alcohol dependence and drug abuse.
- Patients with known hypersensitivity to medicines or foods;
- Patients taking anticholinergic agents or antihistaminic agents;
- Patients who had been hospitalized continuously for more than 3 months before the screening.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease: A Multi-center Single-arm Study in China
This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in China.
Read the detailed description
This study is a multi-center, single-arm, open labeling clinical trial, which the objective is to evaluate the safety and Efficacy of donepezil in Alzheimer's disease( AD) patients in China, and investigate the relationship between Apo-E gene type with adverse events of donepezil.
- Conditions
- Alzheimer's Disease
- Being tested
- Donepezil
- Keywords
- AD, Donepezil, Safety
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Also called Aricept
Eligible patients were treated with Aricept® 10 mg/day for 20 weeks of study period. Aricept® should be taken at night, just prior to sleeping. If patient cannot endure 10mg/d，the dose could be reduce to 5mg/d for 4 weeks and then increase back to 10mg/d. Patients who could not endure the 10mg/d titration the 2nd time and were put back to 5mg/d or discontinuance of Aricept® should be considered as withdrawal from the study. There were a visit (visit 1) at week 0, the end of week 4 (visit 2) and the end of week 20 (visit 3), respectively.
| Study group | Role | What they receive |
|---|---|---|
| donepezil | Other | This is a multi-center single-arm study, which assess the safety and efficacy of donepezil in mild to moderate Alzheimer's disease in China. Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events (AEs)
Physical examinations such as vital signs and weight, clinical laboratory tests, and electrocardiograms (ECGs) during the 20 weeks.
Measured: 20 weeks
Secondary outcomes (5)
Number of Patients Who Withdrew From the Trial Due to Adverse Events.
Number of patients who withdrew due to adverse events
Measured: 20 weeks
Changes in Mini-Mental State Examination Scores From Baseline
Comparison of Mental state examination (MMSE) scores (range 0-30) at 4 weeks and 20 weeks with baseline in mild to moderate AD patients. A higher score indicates better cognitive function.Higher score indicates better cognition function.
Measured: Baseline, 4, 20 weeks
Changes in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores From Baseline
Comparison of Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scores (range 0-78) at 4 weeks and 20 weeks with baseline scores in patients with mild to moderate Alzheimer's Disease. A higher score indicates better activities of daily living (ADL).
Measured: Baseline, 4, 20 weeks
Correlation Between Apolipoprotein E.(APOE) Genotype and Incidence of Adverse Events of Donepezil
Comparison of incidence of adverse events among patients with different APOE genotypes
Measured: 20 weeks
APOE Genotype
A patient's APOE genotype (ɛ2/ɛ2, ɛ3/ɛ3, ɛ4/ɛ4, ɛ2/ɛ3, ɛ2/ɛ4 and ɛ3/e4) was tested by tested by Sanger sequencing from blood collected from the the patient at Visit 2.
APOE genotype is not mandatory
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- multi-center, single-arm, open labeling clinical trial
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai China Inc., Xuanwu Hospital, Beijing
- Responsible party
- Principal investigator, Jianping Jia, Beijing Friendship Hospital
- Investigators
- Cuibai Wei, MD,PhD, Study director, Dept of Neurology, Beijing Friendship Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787746
- Sponsor's protocol ID
- STD-CHINA-001
- Acronym
- STDMMAD
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2016
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No data will be share.
Publications
Jia J, Wei C, Chen W, Jia L, Zhou A, Wang F, Tang Y, Xu L. Safety and Efficacy of Donepezil 10 mg/day in Patients with Mild to Moderate Alzheimer's Disease. J Alzheimers Dis. 2020;74(1):199-211. doi: 10.3233/JAD-190940.
PubMed 31985467
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease: A Multi-center Single-arm Study in China
- ClinicalTrials.gov ID
- NCT02787746
- Acronym / sponsor ID
- STDMMAD / STD-CHINA-001
- Conditions
- Alzheimer's Disease
- Keywords
- AD, Donepezil, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Eisai China Inc., Xuanwu Hospital, Beijing
- Study start
- Apr 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in China.
Detailed description
This study is a multi-center, single-arm, open labeling clinical trial, which the objective is to evaluate the safety and Efficacy of donepezil in Alzheimer's disease( AD) patients in China, and investigate the relationship between Apo-E gene type with adverse events of donepezil.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multi-center, single-arm, open labeling clinical trial
| Arm | Type | Receives |
|---|---|---|
| donepezil | Other | Drug: DonepezilThis is a multi-center single-arm study, which assess the safety and efficacy of donepezil in mild to moderate Alzheimer's disease in China. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients between 50 and 85 years of age.
- 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.
- 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).
- 5mg daily of Donepezil for at least four weeks before the screening.
- Patient with exclusive caregiver.
Key exclusion criteria (8 listed)
- Patients with vascular dementia, other types of dementia or with other psychiatric or neurological disorders (e.g. delirium, depression, Parkinson's disease, etc.).
- 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]).
- Epilepsy or head trauma resulting in unconsciousness that occurred in the two years prior to the screening.
- Patients with hematologic diseases (such as anemia, granulocytes, leukemia, etc.), tumor, neoplasms within 2 years prior to the screening.
- Patients with a history of alcohol dependence and drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonepezilAlso: AriceptEligible patients were treated with Aricept® 10 mg/day for 20 weeks of study period. Aricept® should be taken at night, just prior to sleeping. If patient cannot endure 10mg/d，the dose could be reduce to 5mg/d for 4 weeks and then increase back to 10mg/d. Patients who could not endure the 10mg/d titration the 2nd time and were put back to 5mg/d or discontinuance of Aricept® should be considered as withdrawal from the study. There were a visit (visit 1) at week 0, the end of week 4 (visit 2) and the end of week 20 (visit 3), respectively. | Drug | donepezil |
Primary outcome
Number of Patients With Adverse Events (AEs)
Time frame: 20 weeks
Physical examinations such as vital signs and weight, clinical laboratory tests, and electrocardiograms (ECGs) during the 20 weeks.
5 secondary outcomes
Number of Patients Who Withdrew From the Trial Due to Adverse Events.
Time frame: 20 weeks
Changes in Mini-Mental State Examination Scores From Baseline
Time frame: Baseline, 4, 20 weeks
Changes in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores From Baseline
Time frame: Baseline, 4, 20 weeks
Correlation Between Apolipoprotein E.(APOE) Genotype and Incidence of Adverse Events of Donepezil
Time frame: 20 weeks
APOE Genotype
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31985467Jia J, Wei C, Chen W, Jia L, Zhou A, Wang F, Tang Y, Xu L. Safety and Efficacy of Donepezil 10 mg/day in Patients with Mild to Moderate Alzheimer's Disease. J Alzheimers Dis. 2020;74(1):199-211. doi: 10.3233/JAD-190940.
- Individual participant dataSharing planned: No. No data will be share.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cuibai Wei, MD,PhD study director
Dept of Neurology, Beijing Friendship Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil in people with Alzheimer's Disease, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Adverse Events (AEs) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02787746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.