Alzheimer DiseasePhase 2NCT05670912
Efficacy and Safety of Wei Li Bai Capsules in the Treatment of Alzheimer's Disease
A Phase 2 study testing Wei Li Bai capsules in people with Alzheimer Disease, run by Capital Medical University at 3 sites in China.
Trial summary
In clinical trials of preclinical pharmacodynamic studies, Wei Li Bai capsules has been proved to significantly improve the learning and memory ability of Alzheimer's disease model. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Wei Li Bai capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 3 sitesChina
- Study dates
- 1 Oct 2022to 12 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age 50 to 80 years old (including 50 and 80 years old), male or female;
- Meet the diagnostic criteria of "likely ad dementia" of the National Institute on aging Alzheimer's disease association (NIA-AA) (2011);
- The subjects are primary school graduates / graduates and above, and have the ability to complete the cognitive ability test and other tests specified in the program;
- Memory loss lasted for at least 6 months and tended to worsen gradually;
- Subjects with mild or moderate illness: 11 ≤ total score of MMSE ≤ 26;
- Total score of Clinical Dementia Rating Scale (CDR):
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- Mild dementia: CDR = 1.0; Moderate dementia: CDR = 2.0;
- The total score of HIS ≤ 4;
- The total score of Hamilton Depression Scale (HAMD 17 item version) is ≤ 10;
- If the subject is currently receiving an approved AD treatment, such as acetylcholinesterase inhibitors (AChEI) and/or memantine, they must have been using a stable dose for at least 4 weeks prior to baseline and maintain a stable dose throughout the study;
- There was no obvious positive sign in nervous system examination;
- Coronal scanning of head MRI in screening stage: the MTA grade of medial temporal lobe atrophy visual assessment scale is grade 1-2. If the subject can provide the head MRI film that meets the requirements within 3 month before screening, it can be used as the basis for enrollment without repeated shooting; If the researcher cannot judge whether the subject's condition has changed, the coronal MRI scan of the head before enrollment can be added;
- The subjects should have stable and reliable caregivers, who will take care of them at least 3 days a week and at least 4 hours a day. The caregivers will accompany the subjects to participate in the whole process of the study. Caregivers must accompany the subjects to the study visit and assist the investigator in completing the Neuropsychiatric Inventory (NPI), Alzheimer's Disease Collaborative Study-Ability of Daily Living Scale (ADCS-ADL), and Clinician Interview Based Impression of Severity (CIBIC -plus), and other scale scores;
- Agree to participate and sign the informed consent form by the legal guardian. Due to the subject's limited cognitive ability and other reasons, the subject's signature is allowed to be left blank, and the reason is explained. In addition, the legal guardian shall sign the reason statement, and the legal guardian shall sign the informed consent.
Who cannot join
- During screening, MRI examination showed significant focal lesions, fulfilling one of the following conditions:
- ① There were more than 2 infarcts with diameter > 2 cm at any site;
- ② MRI examination showed that there were infarcts with arbitrary diameter in key parts (such as thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, angular gyrus, cortex and other subcortical gray matter nuclei);
- ③ Fazekas scale grade of white matter lesions >2;
- ④ There are other imaging evidences that do not support mild and moderate AD.
- Dementia caused by other reasons: vascular dementia, central nervous system infection, Creutzfeldt Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic dementia, other physical and chemical factors (such as drug poisoning, alcoholism, carbon monoxide poisoning, etc.), important physical diseases (such as hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space occupying lesions (such as subdural hematoma, brain tumor), endocrine disorders (such as thyroid disease, parathyroid disease), and vitamin B12, folic acid deficiency or any other known cause;
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- Have suffered from central nervous system diseases (including stroke, optic neuromyelitis, epilepsy, etc.);
- Subjects who were diagnosed with psychiatric disorders according to DSM-V criteria, including schizophrenia or other mental diseases, bipolar disorder, severe depression or delirium;
- Abnormal laboratory indexes: liver function (ALT and AST) exceeded 1.5×ULN, renal function (CR) exceeded 1.5×ULN, and creatine kinase exceeded 2×ULN;
- Untreated hypertensive and hypotensive subjects at screening, or hypertensive subjects with uncontrolled hypertension after treatment; subjects with good blood pressure control after treatment can be determined by the investigator to be suitable for inclusion in this study;
- Within 1 month of the screening visit, the subject has new or ongoing unstable or serious heart, lung, liver, kidney and hematopoietic diseases according to the judgment of the researcher, and does not meet the conditions for clinical research;
- Clinically, people with significant allergic reaction history, especially drug allergy history, or known allergy to this product and its excipients;
- Dyspepsia, esophageal reflux, gastric bleeding or peptic ulcer disease, frequent heartburn (≥ once a week) or any surgical operation that may affect drug absorption (such as partial / total gastrectomy, partial / total small bowel resection and cholecystectomy) within 6 months before screening;
- Alcohol or drug abusers;
- Human immunodeficiency virus antibody (ant HIV) and Treponema pallidum antibody (ant TP) are positive;
- Those who are currently using monoclonal antibody drugs for Alzheimer's disease (e.g., lecanemab, domanemab, etc.), psychotropic drugs, anti-Parkinson drugs, and opioid analgesics within 1 month before the visit;
- There are uncorrectable visual and auditory disorders, and the neuropsychological test and scale evaluation cannot be completed;
- Female subjects with positive pregnancy test or lactation and subjects unable to take effective contraceptive measures or have family planning;
- Participated in other clinical trials within 3 months before the screening visit;
- There are other situations that the researcher believes are not suitable to participate in this study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Friendship Hospital, Capital Medical University
Beijing
Xuanwu Hospital of Capital Medical University
Beijing
China-Japan Friendship Hospital
Chaoyang, Beijing Municipality
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center II Clinical Trial to Evaluate the Efficacy and Safety of Wei Li Bai Capsules in the Treatment of Mild to Moderate Alzheimer's Disease
In clinical trials of preclinical pharmacodynamic studies, Wei Li Bai capsules has been proved to significantly improve the learning and memory ability of Alzheimer's disease model. In this study, the researchers will use a multicenter, randomized, double-blind, placebo-controlled parallel method to recruit Alzheimer's disease patients to confirm the efficacy and safety of Wei Li Bai capsules. Confirmation of drug efficacy will be observed through changes in Alzheimer's disease patients' general cognitive function scores, scores of different cognitive domains, daily living activities, and symptom severities.
Read the detailed description
Wei Li Bai Capsule is composed of sodium ferulate tablets, L-rhamnose and chrysin. Sodium ferulate tablet is a domestically marketed drug, L-rhamnose is a marketed food additive, and chrysin is a dietary supplement. All of them have been widely used and their safety has been confirmed. In addition, since these three compounds all show good potential in the treatment of Alzheimer's disease, and play an important role in regulating metabolism, improving blood circulation and anti-inflammatory and antioxidant, this study will explore the synergistic effect of Wei Libai capsule in patients with mild and moderate Alzheimer's disease in 130 subjects.
- Conditions
- Alzheimer Disease
- Being tested
- Wei Li Bai capsules, Placebo Comparator of Wei Li Bai capsules
- Keywords
- Alzheimer disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wei Li Bai capsulesDrug
The distribution ratio between the groups was 1:1, and the stratification factor was the degree of illness CDR score. In the study, the entry of each subject into the active group or placebo group will be determined by the randomized system.
Placebo Comparator of Wei Li Bai capsulesDrug
The distribution ratio between the groups was 1:1, and the stratification factor was the degree of illness CDR score. In the study, the entry of each subject into the active group or placebo group will be determined by the randomized system.
| Study group | Role | What they receive |
|---|---|---|
| active group | Experimental | Take 2 tablets each time (study drug), 3 times a day, a total of 0.9g per day. Take it with warm water half an hour before meals.
Specifications: 0.15g/ pill (42mg sodium ferulate dihydrate, 42mg rhamnose monohydrate, 66mg chrysin) Receives: Drug: Wei Li Bai capsules |
| control group | Placebo comparator | Take 2 tablets of the control drug (placebo) each time, 3 times a day, 0.9g a day. Take it with warm water half an hour before meals.
Specification: 0.15g/ grain (microcrystalline cellulose) Receives: Drug: Placebo Comparator of Wei Li Bai capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-Cognitive section(ADAS-cog/11)
Differences between the active group in changes in ADAS cog/11 scores (relative to baseline) at weeks 13 and 26 were compared with the placebo group.
The ADAS-cog assesses cognitive function in seven components: word recall, instruction, structural practice, naming, conceptual practice, orientation, and word recognition. The total score ranges from 0 to 70, with lower scores representing milder disease.
Measured: Change from baseline in ADAS-cog scores at Week 26.
Secondary outcomes (4)
Alzheimer's Disease Co-operative Study Activities of Daily Living (ADCS-ADL)
Differences between the active group in changes in ADCS-ADL scores (relative to baseline) at weeks 13 and 26 were compared with the placebo group.
The ADCS-ADL scale can reflect the degree of impairment of the subjects' daily life ability, with a total score of 78 points. The higher the score, the better the subjects' living ability.
Measured: Change from baseline in ADCS-ADL scores at Week 26.
Clinician Interview Based Impression of Severity (CIBIC-plus)
Differences between the active group in changes in CIBIC-plus scores (relative to baseline) at weeks 13 and 26 were compared with the placebo group.
The CIBIC-plus scale is based on interviews with patients and their caregivers by research physicians to ask, record and assess changes in patients' conditions. Outcomes assessed were: Caregiver Meeting-Clinical Impression Change, Subject Meeting-Clinical Impression Change, and Overall Clinical Impression Change.
Measured: Change from baseline in CIBIC-plus scores at Week 26.
Neuropsychiatric Inventory (NPI)
Differences in changes in 12-item behavioral domain scores (relative to baseline) on the NPI scale at weeks 13 and 26 between the active group compared with placebo group.
The NPI scale is an interview conducted by the research doctor based on the patient's caregiver to ask the patient's mental and emotional changes. The questions included 12 items including delusions, hallucinations, depression, and anxiety, each of which identified the severity, frequency, and psychological stress of the caregiver.
Measured: Change from baseline in NPI's 12 behavioral domain scores at week 26.
Neuropsychiatric Inventory (NPI)
Differences in changes in caregiver stress scores (relative to baseline) on the NPI scale at weeks 13 and 26 between the active group compared with placebo.
Measured: Change from baseline in Caregiver Stress Score on the NPI Scale at Week 26.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Oct 2022
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
Why it stopped: Due to the inability to complete subject enrollment and follow-up as originally scheduled, coupled with funding shortages and overall strategic adjustments from the sponsor, the study was terminated on November 12, 2024.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Beijing Friendship Hospital
- Responsible party
- Principal investigator, Jianping Jia, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670912
- Sponsor's protocol ID
- WLB-2022
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center II Clinical Trial to Evaluate the Efficacy and Safety of Wei Li Bai Capsules in the Treatment of Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05670912
- Acronym / sponsor ID
- WLB-2022
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the inability to complete subject enrollment and follow-up as originally scheduled, coupled with funding shortages and overall strategic adjustments from the sponsor, the study was terminated on November 12, 2024.
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Beijing Friendship Hospital
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 4 Jan 2023 (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.
In clinical trials of preclinical pharmacodynamic studies, Wei Li Bai capsules has been proved to significantly improve the learning and memory ability of Alzheimer's disease model. In this study, the researchers will use a multicenter, randomized, double-blind, placebo-controlled parallel method to recruit Alzheimer's disease patients to confirm the efficacy and safety of Wei Li Bai capsules. Confirmation of drug efficacy will be observed through changes in Alzheimer's disease patients' general cognitive function scores, scores of different cognitive domains, daily living activities, and symptom severities.
Detailed description
Wei Li Bai Capsule is composed of sodium ferulate tablets, L-rhamnose and chrysin. Sodium ferulate tablet is a domestically marketed drug, L-rhamnose is a marketed food additive, and chrysin is a dietary supplement. All of them have been widely used and their safety has been confirmed. In addition, since these three compounds all show good potential in the treatment of Alzheimer's disease, and play an important role in regulating metabolism, improving blood circulation and anti-inflammatory and antioxidant, this study will explore the synergistic effect of Wei Libai capsule in patients with mild and moderate Alzheimer's disease in 130 subjects.
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 |
|---|---|---|
| active group | Experimental | Drug: Wei Li Bai capsulesTake 2 tablets each time (study drug), 3 times a day, a total of 0.9g per day. Take it with warm water half an hour before meals. Specifications: 0.15g/ pill (42mg sodium ferulate dihydrate, 42mg rhamnose monohydrate, 66mg chrysin) |
| control group | Placebo comparator | Drug: Placebo Comparator of Wei Li Bai capsulesTake 2 tablets of the control drug (placebo) each time, 3 times a day, 0.9g a day. Take it with warm water half an hour before meals. Specification: 0.15g/ grain (microcrystalline cellulose) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 50 to 80 years old (including 50 and 80 years old), male or female;
- Meet the diagnostic criteria of "likely ad dementia" of the National Institute on aging Alzheimer's disease association (NIA-AA) (2011);
- The subjects are primary school graduates / graduates and above, and have the ability to complete the cognitive ability test and other tests specified in the program;
- Memory loss lasted for at least 6 months and tended to worsen gradually;
- Subjects with mild or moderate illness: 11 ≤ total score of MMSE ≤ 26;
Key exclusion criteria (20 listed)
- During screening, MRI examination showed significant focal lesions, fulfilling one of the following conditions:
- ① There were more than 2 infarcts with diameter > 2 cm at any site;
- ② MRI examination showed that there were infarcts with arbitrary diameter in key parts (such as thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, angular gyrus, cortex and other subcortical gray matter nuclei);
- ③ Fazekas scale grade of white matter lesions >2;
- ④ There are other imaging evidences that do not support mild and moderate AD.
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 |
|---|---|---|
| Wei Li Bai capsulesThe distribution ratio between the groups was 1:1, and the stratification factor was the degree of illness CDR score. In the study, the entry of each subject into the active group or placebo group will be determined by the randomized system. | Drug | active group |
| Placebo Comparator of Wei Li Bai capsulesThe distribution ratio between the groups was 1:1, and the stratification factor was the degree of illness CDR score. In the study, the entry of each subject into the active group or placebo group will be determined by the randomized system. | Drug | control group |
Primary outcome
Alzheimer's Disease Assessment Scale-Cognitive section(ADAS-cog/11)
Time frame: Change from baseline in ADAS-cog scores at Week 26.
Differences between the active group in changes in ADAS cog/11 scores (relative to baseline) at weeks 13 and 26 were compared with the placebo group. The ADAS-cog assesses cognitive function in seven components: word recall, instruction, structural practice, naming, conceptual practice, orientation, and word recognition. The total score ranges from 0 to 70, with lower scores representing milder disease.
4 secondary outcomes
Alzheimer's Disease Co-operative Study Activities of Daily Living (ADCS-ADL)
Time frame: Change from baseline in ADCS-ADL scores at Week 26.
Clinician Interview Based Impression of Severity (CIBIC-plus)
Time frame: Change from baseline in CIBIC-plus scores at Week 26.
Neuropsychiatric Inventory (NPI)
Time frame: Change from baseline in NPI's 12 behavioral domain scores at week 26.
Neuropsychiatric Inventory (NPI)
Time frame: Change from baseline in Caregiver Stress Score on the NPI Scale at Week 26.
Results and safety
The study was stopped early (reason given: Due to the inability to complete subject enrollment and follow-up as originally scheduled, coupled with funding shortages and overall strategic adjustments from the sponsor, the study was terminated on November 12, 2024.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Wei Li Bai capsules in people with Alzheimer Disease, run by Capital Medical University at 3 sites 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 14 inclusion and 20 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: stopped early, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the inability to complete subject enrollment and follow-up as originally scheduled, coupled with funding shortages and overall strategic adjustments from the sponsor, the study was terminated on November 12, 2024.). Results are not available in the source record.
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?
Alzheimer's Disease Assessment Scale-Cognitive section(ADAS-cog/11) (time frame: Change from baseline in ADAS-cog scores at Week 26.). 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 4 Dec 2024.