Alzheimer DementiaPhase 2/3NCT07066826
Clinical Study to Evaluate the Efficacy and Safety of Huperzine A Controlled-Release Tablets in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
A Phase 2/3 study testing Donepezil hydrochloride tablets in people with Alzheimer Dementia, run by Wanbangde Pharmaceutical Group Co., LTD at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group clinical trial. The dose confirmation stage is designed to evaluate the efficacy and safety of different doses of huperzine A controlled-release tablets in patients with mild-to-moderate dementia of the… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Dementia
- What is being tested?
- Donepezil hydrochloride tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2025to 15 Aug 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- The subject voluntarily agrees to participate in the study and signs the informed consent form jointly with a legally authorized representative (LAR). If the subject is unable to sign due to cognitive impairment or other reasons, the signature field for the subject may be left blank, with the reason specified and signed by the LAR. In such cases, the LAR must sign the informed consent form on behalf of the subject.
- Aged ≥50 and ≤85 years, male or female.
- Meets the diagnostic criteria for probable Alzheimer's disease (AD) dementia according to the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) guidelines.
- Has experienced memory impairment for at least 12 months, with a chronic and progressively worsening course.
- Has received ≥5 years of formal education and is able to complete the protocol-specified cognitive assessments.
- Diagnosed with Stage 4 or 5 (mild to moderate dementia) according to the Revised Clinical Staging of Alzheimer's Disease (2024) (i.e., Clinical Dementia Rating [CDR] global score of 1 or 2).
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- Total score on the Mini-Mental State Examination (MMSE) is between 11 and 26 inclusive.
- Has undergone a cranial MRI scan showing a Medial Temporal Atrophy (MTA) visual rating scale grade ≥1. If the subject has completed an eligible MRI at this or another tertiary hospital within 6 months prior to screening, and it meets the protocol requirements, re-scanning is not required.
- Capable of undergoing positron emission tomography (PET) imaging.
- Hachinski Ischemic Score (HIS) ≤ 4.
- Hamilton Depression Rating Scale (HAMD-17) score of ≤10.
- No obvious focal neurological signs on physical examination, except those attributable to peripheral injury.
- Has a stable and reliable caregiver, or is in frequent contact with a caregiver (at least 4 days per week and ≥2 hours per day). The caregiver must accompany the subject to study visits, provide reliable information for scale assessments based on sufficient interaction and communication with the subject, and should remain the same throughout the study whenever possible.
Who cannot join
- Subjects who are allergic to the active ingredient or excipients of huperzine A controlled-release tablets or donepezil, or those with lactose intolerance.
- Cognitive impairment or dementia not caused by Alzheimer's disease (AD), including:
- Other neurodegenerative diseases (e.g., dementia with Lewy bodies, frontotemporal degeneration, Huntington's disease, Parkinson's disease); (2) Non-degenerative neurological conditions causing cognitive impairment or dementia (e.g., vascular cognitive impairment or dementia, hydrocephalus, encephalitis, hypoxic brain injury, traumatic brain injury); (3) Non-neurological systemic diseases causing cognitive impairment or dementia (e.g., endocrine disorders such as hypothyroidism, hepatic insufficiency, hepatic encephalopathy, dialysis encephalopathy, neurosyphilis, HIV); (4) Cognitive impairment or dementia caused by vitamin deficiencies (e.g., folate or vitamin B12 deficiency).
- 3.Subjects diagnosed, per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with psychiatric disorders within the past 12 months that are unstable or may interfere with study assessments, including but not limited to schizophrenia or other psychotic disorders, bipolar disorder, major depressive disorder, delirium, or substance (including alcohol) use disorders with dependence.
- 4.Subjects with significant focal brain lesions on MRI, including but not limited to any of the following (if a qualifying head MRI was performed within 6 months prior to screening and meets protocol requirements, repeat imaging is not required):
- Presence of lesions indicating large-area cerebral infarction;
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- Infarcts in critical brain regions (e.g., thalamus, hippocampus, entorhinal cortex, parahippocampal gyrus, angular gyrus, cortical or subcortical gray matter nuclei);
- More than two infarcts with a diameter >2 cm, and deemed by the investigator to impact cognitive assessments;
- Multiple lacunar infarcts, deemed by the investigator to impact cognitive assessments;
- Severe white matter lesions;
- Intracerebral hemorrhage deemed likely to affect cognitive assessments by the investigator;
- Hydrocephalus.
- 5.Subjects with uncontrolled seizures (and/or epilepsy syndromes), or those with cognitive impairment caused or potentially caused by recurrent seizures or antiepileptic drug use.
- 6.Subjects who experienced acute cardiovascular or cerebrovascular events within 3 months prior to screening (e.g., unstable angina, second- or third-degree atrioventricular block or other serious arrhythmias, myocardial infarction, decompensated congestive heart failure of NYHA class III or IV, transient ischemic attack, or ischemic stroke).
- 7.Subjects with uncontrolled hypertension or hypotension at screening (defined as systolic blood pressure ≥160 mmHg or <90 mmHg, or diastolic blood pressure ≥100 mmHg or <60 mmHg after pharmacologic or non-pharmacologic treatment); subjects with slight deviations beyond this range but deemed clinically insignificant by the investigator may be included.
- 8.Subjects with serious active gastrointestinal disorders (e.g., severe gastroesophageal reflux, gastrointestinal bleeding, or peptic ulcers) within 3 months prior to screening, or who have undergone any surgical procedures that may affect drug absorption (e.g., total gastrectomy, total small bowel resection).
- 9.Subjects with other uncontrolled clinical conditions (e.g., malignancies, severe infectious diseases, respiratory diseases).
- 10.Subjects with sinus bradycardia at screening (resting heart rate <60 bpm) that is deemed clinically significant by the investigator.
- 11.Subjects with corrected QT interval using Fridericia's formula (QTcF) >450 ms in males or >470 ms in females at screening or baseline.
- 12.Subjects with renal dysfunction (serum creatinine [Scr] >1.5× the upper limit of normal [ULN] per the study center laboratory) or hepatic dysfunction (ALT or AST >2× ULN).
- 13.Subjects with thyroid function abnormalities at screening that are deemed clinically significant and unsuitable for study participation by the investigator.
- 14.Subjects who test positive for syphilis antibodies or HIV antibodies. 15.Subjects who received donanemab within 2 months prior to screening; lecanemab within 5 weeks prior to screening; or any other medication for the treatment of AD or cognitive enhancement within 4 weeks prior to screening, including but not limited to cholinesterase inhibitors, NMDA receptor antagonists, and other nootropic agents.
- 16.Subjects who participated in any drug clinical trial (excluding vitamins and minerals) within 1 month prior to screening or 7 half-lives of the study drug (whichever is longer), or who are currently participating in another clinical trial.
- 17.Subjects who are unable to complete the required scale assessments due to uncorrectable vision or hearing impairments.
- 18.Subjects who are unable to complete study-required assessments due to personal limitations, such as contraindications to MRI scanning.
- 19.Subjects of childbearing potential (male or female) who are unwilling to use effective contraception from the start of the study until 6 months after the end of the study, and/or female subjects of childbearing potential who are unwilling or unable to undergo pregnancy testing.
- 20.Pregnant or breastfeeding women. 21.Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing
About this study
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel-Group Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Huperzine A Controlled-Release Tablets in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
This study is a multicenter, randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group clinical trial. The dose confirmation stage is designed to evaluate the efficacy and safety of different doses of huperzine A controlled-release tablets in patients with mild-to-moderate dementia of the Alzheimer's type, with the goal of providing a basis for dose selection in the subsequent efficacy confirmation stage. The efficacy confirmation stage aims to assess the effect of huperzine A controlled-release tablets on cognitive function and functional abilities in patients with mild-to-moderate dementia of the Alzheimer's type.In the open-label extension stage, all subjects will receive huperzine A controlled-release tablets until Week 52, to further evaluate the long-term efficacy and safety of the treatment.
- Conditions
- Alzheimer Dementia
- Being tested
- Huperzine A Controlled-Release Tablets, Donepezil hydrochloride tablets, Huperzine A controlled-release tablets placebo; Donepezil hydrochloride tablets placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huperzine A Controlled-Release TabletsDrug
During the trial, the patients should take huperzine A controlled-release tablets in the morning
Donepezil hydrochloride tabletsDrug
During the trial, the patients should take donepezil hydrochloride tablets before going to bed in the evening
Huperzine A controlled-release tablets placebo; Donepezil hydrochloride tablets placeboDrug
During the trial, the patients should take huperzine A controlled-release tablets placebo in the morning and donepezil hydrochloride tablets placebo before going to bed in the evening
| Study group | Role | What they receive |
|---|---|---|
| Huperzine A controlled-release tablets | Experimental | Not described Receives: Drug: Huperzine A Controlled-Release Tablets |
| Donepezil hydrochloride tablets | Active comparator | Not described Receives: Drug: Donepezil hydrochloride tablets |
| Huperzine A controlled-release tablets placebo; Donepezil hydrochloride tablets placebo | Placebo comparator | Not described Receives: Drug: Huperzine A controlled-release tablets placebo; Donepezil hydrochloride tablets placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-Cog11
ADAS-Cog11: Alzheimer's Disease Assessment Scale-Cognitive Subscale. Score range: 0-70. Lower = better
Measured: week24
ADCS-ADL
ADCS-ADL: Alzheimer's Disease Cooperative Study - Activities of Daily Living. Score range: 0-78. Higher= better
Measured: week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start29 Aug 2025
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wanbangde Pharmaceutical Group Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066826
- Sponsor's protocol ID
- WBD-SSJJK-R01
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel-Group Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Huperzine A Controlled-Release Tablets in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
- ClinicalTrials.gov ID
- NCT07066826
- Acronym / sponsor ID
- WBD-SSJJK-R01
- Conditions
- Alzheimer Dementia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Wanbangde Pharmaceutical Group Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group clinical trial. The dose confirmation stage is designed to evaluate the efficacy and safety of different doses of huperzine A controlled-release tablets in patients with mild-to-moderate dementia of the Alzheimer's type, with the goal of providing a basis for dose selection in the subsequent efficacy confirmation stage. The efficacy confirmation stage aims to assess the effect of huperzine A controlled-release tablets on cognitive function and functional abilities in patients with mild-to-moderate dementia of the Alzheimer's type.In the open-label extension stage, all subjects will receive huperzine A controlled-release tablets until Week 52, to further evaluate the long-term efficacy and safety of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Huperzine A controlled-release tablets | Experimental | Drug: Huperzine A Controlled-Release Tablets |
| Donepezil hydrochloride tablets | Active comparator | Drug: Donepezil hydrochloride tablets |
| Huperzine A controlled-release tablets placebo; Donepezil hydrochloride tablets placebo | Placebo comparator | Drug: Huperzine A controlled-release tablets placebo; Donepezil hydrochloride tablets placebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The subject voluntarily agrees to participate in the study and signs the informed consent form jointly with a legally authorized representative (LAR). If the subject is unable to sign due to cognitive impairment or other reasons, the signature field for the subject may be left blank, with the reason specified and signed by the LAR. In such cases, the LAR must sign the informed consent form on behalf of the subject.
- Aged ≥50 and ≤85 years, male or female.
- Meets the diagnostic criteria for probable Alzheimer's disease (AD) dementia according to the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) guidelines.
- Has experienced memory impairment for at least 12 months, with a chronic and progressively worsening course.
- Has received ≥5 years of formal education and is able to complete the protocol-specified cognitive assessments.
Key exclusion criteria (27 listed)
- Subjects who are allergic to the active ingredient or excipients of huperzine A controlled-release tablets or donepezil, or those with lactose intolerance.
- Cognitive impairment or dementia not caused by Alzheimer's disease (AD), including:
- Other neurodegenerative diseases (e.g., dementia with Lewy bodies, frontotemporal degeneration, Huntington's disease, Parkinson's disease); (2) Non-degenerative neurological conditions causing cognitive impairment or dementia (e.g., vascular cognitive impairment or dementia, hydrocephalus, encephalitis, hypoxic brain injury, traumatic brain injury); (3) Non-neurological systemic diseases causing cognitive impairment or dementia (e.g., endocrine disorders such as hypothyroidism, hepatic insufficiency, hepatic encephalopathy, dialysis encephalopathy, neurosyphilis, HIV); (4) Cognitive impairment or dementia caused by vitamin deficiencies (e.g., folate or vitamin B12 deficiency).
- 3.Subjects diagnosed, per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with psychiatric disorders within the past 12 months that are unstable or may interfere with study assessments, including but not limited to schizophrenia or other psychotic disorders, bipolar disorder, major depressive disorder, delirium, or substance (including alcohol) use disorders with dependence.
- 4.Subjects with significant focal brain lesions on MRI, including but not limited to any of the following (if a qualifying head MRI was performed within 6 months prior to screening and meets protocol requirements, repeat imaging is not required):
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 |
|---|---|---|
| Huperzine A Controlled-Release TabletsDuring the trial, the patients should take huperzine A controlled-release tablets in the morning | Drug | Huperzine A controlled-release tablets |
| Donepezil hydrochloride tabletsDuring the trial, the patients should take donepezil hydrochloride tablets before going to bed in the evening | Drug | Donepezil hydrochloride tablets |
| Huperzine A controlled-release tablets placebo; Donepezil hydrochloride tablets placeboDuring the trial, the patients should take huperzine A controlled-release tablets placebo in the morning and donepezil hydrochloride tablets placebo before going to bed in the evening | Drug | Huperzine A controlled-release tablets placebo; Donepezil hydrochloride tablets placebo |
Primary outcome
ADAS-Cog11
Time frame: week24
ADAS-Cog11: Alzheimer's Disease Assessment Scale-Cognitive Subscale. Score range: 0-70. Lower = better
ADCS-ADL
Time frame: week24
ADCS-ADL: Alzheimer's Disease Cooperative Study - Activities of Daily Living. Score range: 0-78. Higher= better
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Donepezil hydrochloride tablets in people with Alzheimer Dementia, run by Wanbangde Pharmaceutical Group Co., LTD 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 13 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Li (+8613735826039 ext. 0576-86183918, lijuan@wepon.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-Cog11 (time frame: week24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.