Alzheimer's DementiaPhase 3NCT06534723
Phase 3 Clinical Trial of Wujia Yizhi Granules in the Treatment of Mild-to-moderate Alzheimer's Dementia (Syndrome of Deficiency of Spleen and Kidney)
A Phase 3 study testing Wujia Yizhi granules in people with Alzheimer's Dementia, run by Sichuan Jishengtang Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled phase 3 design aimed at further verifying the safety and efficacy of Wujia Yizhi granules for mild-to-moderate Alzheimer's dementia Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer's Dementia
- What is being tested?
- Wujia Yizhi granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 570 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2024to 1 Dec 2026
- Phase
- Phase 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age range : 50 - 80 years old.
- Informed consent signed and dated by patient or legal representative.
- The participants are mild-to-moderate AD patients who meet the diagnostic criteria for AD proposed by the National Institute on Aging and the Alzheimer's Association (NIA-AA) in 2018 and have a disease course of more than 6 months. If participants lack previous pathological evidence or biomarkers of Alzheimer's dementia, they must have evidence of β-amyloid deposition biomarkers during screening (PET with abnormal amyloid deposition or low cerebrospinal fluid Aβ 42 and Aβ 42/Aβ 40 ratio).
- MMSE score 11 to 26;CDR-GS score 1 to 2 。
Who cannot join
- Participants with non AD induced memory and cognitive impairment, such as diagnosis of other types of dementia, including but not limited to mixed dementia (AD VaD), vascular dementia (VD), Parkinson's disease dementia (PDD), Lewy body dementia (DLB), Huntington's disease related dementia, frontotemporal lobe dementia (FTD), etc; Endocrine system disorders (such as thyroid diseases, parathyroid diseases) and dementia caused by folate, vitamin B12 deficiency, or any other reason; Existence of consciousness disorders, etc.
- Participants have a history of epileptic seizures.
- Participants are psychiatric patients, including but not limited to schizophrenia, affective schizophrenic disorder, bipolar disorder, or delirium.
- HAMD-17 score ≥ 17 points.
- HAMA score ≥ 14 points.
- Participants were taking antidepressants, anxieties, and antipsychotic drugs during screening.
- HIS score ≥ 4 points..
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
Fujian Medical University Affiliated Union Hospital
Fuzhou, Fujian, 350000
About this study
Official title: A 12-month Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Clinical Trial of Wujia Yizhi Granules in the Treatment of Mild-to-moderate Alzheimer's Dementia (Syndrome of Deficiency of Spleen and Kidney).
This study is a randomized, double-blind, placebo-controlled phase 3 design aimed at further verifying the safety and efficacy of Wujia Yizhi granules for mild-to-moderate Alzheimer's dementia
Read the detailed description
This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical trial targeting patients with mild-to-moderate Alzheimer's dementia (TCM differentiated as syndrome of deficiency of spleen and kidney). 570 subjects were recruited and randomly assigned to the experimental and placebo groups at a ratio of 2:1.
- Conditions
- Alzheimer's Dementia
- Being tested
- Wujia Yizhi granules, 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.
Wujia Yizhi granulesDrug
Drug: Wujia Yizhi granuless
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Wujia Yizhi Granules | Experimental | Participants received Wujia Yizhi Granules 6g ,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 months. Receives: Drug: Wujia Yizhi granules |
| Placebo | Placebo comparator | Participants received Wujia Yizhi granules simulator 6g ,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to endpoint in Alzheimer's dementia Assessment Scale-Cognitive subscore (ADAS-Cog12).
The Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-Cog12) is used to assess the cognitive function level of AD subjects. The ADAS-Cog12 score range is 0-75 points, and the higher the score on the scale, the more severe the cognitive impairment.
Measured: Change from Baseline to Month 12
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB).
The Alzheimer's Disease Assessment Scale - Cognitive Scale (CDR-SB) is used to assess the cognitive function level of AD subjects. The CDR-SB score range is 0-3 points, and the higher the score on the scale, the more severe the cognitive impairment.
Measured: Change from Baseline to Month 12
Secondary outcomes (6)
Change from baseline to endpoint in ADAS-Cog12.
The Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-Cog12) is used to assess the cognitive function level of AD subjects. The ADAS-Cog12 score range is 0-75 points, and the higher the score on the scale, the more severe the cognitive impairment.
Measured: Change from Baseline to month 3, 6, and 9
Change from baseline to endpoint in CDR-SB.
The Alzheimer's Disease Assessment Scale - Cognitive Scale (CDR-SB) is used to assess the cognitive function level of AD subjects. The CDR-SB score range is 0-3 points, and the higher the score on the scale, the more severe the cognitive impairment.
Measured: Change from Baseline to month 3, 6, and 9
Change from baseline to endpoint in he Alzheimer's dementia Cooperative Study-Activities of Daily Living (ADCS-ADL) scale.
The Alzheimer's Disease Collaborative Study Group - Activities of Daily Living Scale (ADCS-ADL) is used to evaluate the daily living abilities of AD subjects. The score range of ADCS-ADL is from 0 to 78, with higher numbers indicating better daily functioning.
Measured: Change from Baseline to month 3, 6, 9 and 12
Change from baseline to endpoint in Mini-Mental State Examination (MMSE).
The Simple Intelligent State Examination Scale (MMSE) has a total of 19 items, with scores ranging from 0 to 30. In clinical practice, the diagnostic threshold is usually adjusted based on educational level, with university ≤ 26 points, middle school ≤ 24 points, primary school ≤ 23 points, and illiteracy ≤ 22 points, indicating dementia.
Measured: Change from Baseline to month 3, 6, 9 and 12
Change from baseline to endpoint in Neuropsychiatric Inventory (NPI).
The Neuropsychiatric Inventory (NPI) includes a total of 12 items in 10 behavioral domains and 2 autonomic nervous system domains, with a score range of 0-144. The caregiver distress rating is 0-60, where 0 represents the best, and the higher the score, the higher the level of distress.
Measured: Change from Baseline to month 3, 6, 9 and 12
Change from baseline to endpoint in Traditional Chinese Medicine Syndrome Score
TCM syndrome scale was used to evaluate the changes of TCM symptoms and signs before and after treatment.
Measured: Change from Baseline to month 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start20 Aug 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Jishengtang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaochun Chen, Medical Doctor, Principal investigator, Fujian Medical University Affiliated Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534723
- Sponsor's protocol ID
- KH110-60101
- Status last verified
- Dec 2025
- First submitted
- 3 Jul 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Clinical Trial of Wujia Yizhi Granules in the Treatment of Mild-to-moderate Alzheimer's Dementia (Syndrome of Deficiency of Spleen and Kidney).
- ClinicalTrials.gov ID
- NCT06534723
- Acronym / sponsor ID
- KH110-60101
- Conditions
- Alzheimer's Dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Sichuan Jishengtang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Aug 2024 (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 randomized, double-blind, placebo-controlled phase 3 design aimed at further verifying the safety and efficacy of Wujia Yizhi granules for mild-to-moderate Alzheimer's dementia
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical trial targeting patients with mild-to-moderate Alzheimer's dementia (TCM differentiated as syndrome of deficiency of spleen and kidney). 570 subjects were recruited and randomly assigned to the experimental and placebo groups at a ratio of 2:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wujia Yizhi Granules | Experimental | Drug: Wujia Yizhi granulesParticipants received Wujia Yizhi Granules 6g ,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 months. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received Wujia Yizhi granules simulator 6g ,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 months. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age range : 50 - 80 years old.
- Informed consent signed and dated by patient or legal representative.
- The participants are mild-to-moderate AD patients who meet the diagnostic criteria for AD proposed by the National Institute on Aging and the Alzheimer's Association (NIA-AA) in 2018 and have a disease course of more than 6 months. If participants lack previous pathological evidence or biomarkers of Alzheimer's dementia, they must have evidence of β-amyloid deposition biomarkers during screening (PET with abnormal amyloid deposition or low cerebrospinal fluid Aβ 42 and Aβ 42/Aβ 40 ratio).
- MMSE score 11 to 26;CDR-GS score 1 to 2 。
Key exclusion criteria (7 listed)
- Participants with non AD induced memory and cognitive impairment, such as diagnosis of other types of dementia, including but not limited to mixed dementia (AD VaD), vascular dementia (VD), Parkinson's disease dementia (PDD), Lewy body dementia (DLB), Huntington's disease related dementia, frontotemporal lobe dementia (FTD), etc; Endocrine system disorders (such as thyroid diseases, parathyroid diseases) and dementia caused by folate, vitamin B12 deficiency, or any other reason; Existence of consciousness disorders, etc.
- Participants have a history of epileptic seizures.
- Participants are psychiatric patients, including but not limited to schizophrenia, affective schizophrenic disorder, bipolar disorder, or delirium.
- HAMD-17 score ≥ 17 points.
- HAMA score ≥ 14 points.
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 |
|---|---|---|
| Wujia Yizhi granulesDrug: Wujia Yizhi granuless | Drug | Wujia Yizhi Granules |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change from baseline to endpoint in Alzheimer's dementia Assessment Scale-Cognitive subscore (ADAS-Cog12).
Time frame: Change from Baseline to Month 12
The Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-Cog12) is used to assess the cognitive function level of AD subjects. The ADAS-Cog12 score range is 0-75 points, and the higher the score on the scale, the more severe the cognitive impairment.
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB).
Time frame: Change from Baseline to Month 12
The Alzheimer's Disease Assessment Scale - Cognitive Scale (CDR-SB) is used to assess the cognitive function level of AD subjects. The CDR-SB score range is 0-3 points, and the higher the score on the scale, the more severe the cognitive impairment.
6 secondary outcomes
Change from baseline to endpoint in ADAS-Cog12.
Time frame: Change from Baseline to month 3, 6, and 9
Change from baseline to endpoint in CDR-SB.
Time frame: Change from Baseline to month 3, 6, and 9
Change from baseline to endpoint in he Alzheimer's dementia Cooperative Study-Activities of Daily Living (ADCS-ADL) scale.
Time frame: Change from Baseline to month 3, 6, 9 and 12
Change from baseline to endpoint in Mini-Mental State Examination (MMSE).
Time frame: Change from Baseline to month 3, 6, 9 and 12
Change from baseline to endpoint in Neuropsychiatric Inventory (NPI).
Time frame: Change from Baseline to month 3, 6, 9 and 12
Change from baseline to endpoint in Traditional Chinese Medicine Syndrome Score
Time frame: Change from Baseline to month 3, 6, 9 and 12
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 29 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Xiaochun Chen, Medical Doctor principal investigator
Fujian Medical University Affiliated Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Wujia Yizhi granules in people with Alzheimer's Dementia, run by Sichuan Jishengtang Pharmaceutical 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 4 inclusion and 7 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 29 Dec 2025. 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 phase mean?
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 Lin song (028-81258178, 022516@cnkh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to endpoint in Alzheimer's dementia Assessment Scale-Cognitive subscore (ADAS-Cog12). (time frame: Change from Baseline to Month 12). 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 29 Dec 2025.