To Explore the Therapeutic Potential of Jiedu Yizhi Formula for Alzheimer 's Disease
Changchun University of Chinese Medicine
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Jilin
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Changchun, Jilin, China, 130117
- Changchun University of Traditional Chinese Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
(1) Meet the above NIA-AA AD diagnostic criteria; (2) Meets the diagnostic criteria for traditional Chinese medicine syndromes mentioned above; (3) Age range from 55 to 85 years old, regardless of gender; (4) MMSE scale scores range from 10 to 26 points; (5) The CDR scale scores 1 or 2 points; (6) The HAMD scale score is less than 8 points; (7) HAMA scale score below 7 points; (8) At least 4 elements of kidney deficiency, spleen deficiency, marrow deficiency, blood stasis, and phlegm turbidity syndrome in the PES-D/11 scale score are valid, and may be accompanied by toxic excess syndrome elements (the sum of scores greater than or equal to 7 points is considered valid); (9) HIS scale score below 5 points; (10) Family members agree and sign an informed consent form.
Exclusion Criteria:
(1) Severe dementia patients; (2) Other types of dementia such as vascular dementia, frontotemporal lobe dementia, Lewy body dementia, mixed dementia, as well as secondary dementia caused by infection, poisoning, metabolism, tumors, and other reasons; (3) There are other diseases that may cause cognitive impairment; (4) Patients who cannot fully cooperate with the assessment; (5) Patients with unstable vital signs and critical condition; (6) Patients with concomitant psychiatric disorders; (7) Patients with scores of less than 7 on the PES-D/11 scale for spleen deficiency, kidney deficiency, marrow deficiency, blood stasis, and phlegm turbidity; (8) Patients with long-term alcohol or drug abuse that affects efficacy evaluation; (9) Patients who have experienced serious adverse reactions or allergies to the drugs in this study due to previous use of traditional Chinese medicine.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Jiedu Yizhi Formula
The traditional Chinese medicine treatment group received modified Jiedu Yizhi Formula therapy, with no more than 3 flavors, customized based on syndrome differentiation.
The herbal composition included 10g of Coptis chinensis Franch (Huanglian, Ranunculaceae, rhizome), 20g of Alpinia oxyphylla Miq.(Yizhiren, Zingiberaceae, fructus), 10g of Chinemys reevesii(Guibanjiao), 10g of Rheum webbianum (Jiu Dahuang, rhizome), 10g of Cornus officinalis (Shanzhuyu, Cornaceae, fructus), 10g of Pheretima aspergillum (Dilong), and 10g of Oreocome striata (Chuanxiong, Apiaceae, rhizome).
300ml of water decoction juice was prepared from each pair of herbs, and 100ml was taken daily after breakfast and dinner.
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Observation after 24 weeks of drug treatment
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Sham Comparator: Donepezil Hydrochloride Tablets
The Western medicine control group, on the other hand, was administered donepezil hydrochloride (Anlishen 5mg/tablet, from Weicai China Pharmaceutical Co., Ltd.) orally before bedtime at a dosage of 5mg per day.
After 4 weeks of treatment, clinical reactions were assessed, and no significant abnormal clinical reactions were observed.
Subsequently, the dosage was increased to 10mg per day for maintenance therapy, leading to a total of 24 weeks of continuous treatment.
Additionally, both patient groups were provided guidance on actively addressing and managing various risk factors associated with Alzheimer's disease, in conjunction with cognitive behavioral training.
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Donepezil Hydrochloride Tablets
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mini-mental State Examination(MMSE)
Time Frame: 24 weeks
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The most widely used cognitive screening tool in the world today, the MMSE was created by Folstein et al. in 1975.
It is frequently used to measure endpoint outcomes, evaluate cognitive levels, and screen for cognitive impairment.
30 points is the highest score, and 0 points is the lowest.
The better the cognitive function, the higher the score.
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24 weeks
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Montreal Cognitive Assessment (MoCA)
Time Frame: 24 weeks
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Professor Nasreddine and colleagues created MoCA in 2004.
Recall, naming, abstraction, language, attention, visual spatial and executive abilities, and directional abilities are among the eight areas on the scale that assess cognitive performance.
Higher scores indicate stronger cognitive function.
The scores range from 0 to 30.
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24 weeks
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Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog）
Time Frame: 24 weeks
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The 12-item ADAS cog is used to evaluate the degree of memory, language, and other cognitive impairments in people with Alzheimer's disease.
Of them, four evaluate language, five evaluate memory and direction, two evaluate practical competence, and one evaluate focus and attention.
The more severe the cognitive impairment, the higher the score on the ADAS log, which ranges from 0 to 70 points.
The better the therapeutic impact, the lower the score after taking medication.
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24 weeks
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Clinical dementia rating(CDR)
Time Frame: 24 weeks
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CDR (Clinical Dementia Rating) is a standard for evaluating the degree of dementia, which includes a series of cognitive function assessments, including memory, attention, understanding, sense of direction, computational ability, etc. The evaluation results include 0 points, 0.5 points, 1 point, 2 points, 3 points, 0 points indicating normal, and 0.5 points indicating mild dementia, 1 point represents moderate dementia, 2 points represents severe dementia, and 3 points represents terminal dementia. |
24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Activity of daily living（ ADL ）
Time Frame: 24 weeks
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Activity of daily life refers to the necessary activities that a person engages in every day to meet their daily needs, including eating, dressing, washing, bathing, toileting, dressing, etc. Functional movements include turning over, sitting up from bed, transferring, walking, driving a wheelchair, going up and down stairs, etc.
The score ranges from 0 to 100 points, and the higher the score, the stronger the daily living ability.
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24 weeks
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Hamilton Depression Stable （HAMD ）
Time Frame: 24 weeks
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Evaluate mental state using the HAMD scale.During the diagnosis and treatment process, it was found that many AD patients are accompanied by varying degrees of depression, which will also affect the improvement of their cognitive function.
In terms of efficacy evaluation indicators, in addition to evaluating cognitive function scales, HAMD should also be included in the observation indicators.
The score range for each scoring item is 0-4 points, with a total score of 0-76 points.
When scoring, the doctor or evaluator needs to select the scoring item that best matches the symptoms of the evaluated person based on their actual situation, and give corresponding scores.
The higher the score, the more severe the depressive symptoms are.
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24 weeks
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Collaborators and Investigators
Investigators
- Study Director: Wei Zhang, Dr., Affiliated Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CZDSFYLL2023-0010-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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