To Explore the Therapeutic Potential of Jiedu Yizhi Formula for Alzheimer 's Disease

NCT06393413 | Completed Early Phase 1 DMC

• 1 other identifier: CZDSFYLL2023-0010-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

AD patients who met the inclusion criteria in the encephalopathy clinic and treatment area of the Third Clinical Hospital Affiliated to Changchun University of Traditional Chinese Medicine from December 2022 to December 2023 were collected and randomly divided into traditional Chinese medicine experimental group and western medicine control group. The experimental group was treated with Jiedu Yizhi Formula, and the control group was treated with Donepezil Hydrochloride Tablets ( trade name : Aricept ). The two groups were given AD cognitive behavior training and health education at the same time. The course of treatment was 24 weeks. The Western medicine scale was measured before treatment, 12 weeks after treatment and 24 weeks after treatment to evaluate the effect of drugs on cognitive function and daily living ability.

Conditions

Ensure the Legality and Compliance of the Testing Process

Outcome Measures

Primary Outcomes (4)

• Mini-mental State Examination(MMSE)

  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.

  24 weeks

• Montreal Cognitive Assessment (MoCA)

  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.

  24 weeks

• Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog）

  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.

  24 weeks

• Clinical dementia rating(CDR)

  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

Secondary Outcomes (2)

• Activity of daily living（ ADL ）

  24 weeks

• Hamilton Depression Stable （HAMD ）

  24 weeks

Study Arms (2)

Jiedu Yizhi Formula

EXPERIMENTAL

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.

Drug: Jiedu Yizhi Formula

Donepezil Hydrochloride Tablets

SHAM COMPARATOR

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.

Drug: Donepezil Hydrochloride Tablets

Interventions

Jiedu Yizhi Formula DRUG

Observation after 24 weeks of drug treatment

Jiedu Yizhi Formula

Donepezil Hydrochloride Tablets DRUG

Donepezil Hydrochloride Tablets

Donepezil Hydrochloride Tablets

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Changchun University of Chinese Medicine: lead

Study Sites (1)

Changchun University of Traditional Chinese Medicine

Changchun, Jilin, 130117, China

Location

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Wei Zhang, Dr.

  Affiliated Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief investigator

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 1, 2024
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)