Clinical trial NCT06393413: To Explore the Therapeutic Potential of Jiedu Yizhi Formula for Alzheimer 's Disease
Official title: Changchun University of Chinese Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Ensure the Legality and Compliance of the Testing Process
Lead sponsor: Changchun University of Chinese Medicine
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 62
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: From December 2022 to December 2023, we conducted a prospective randomized controlled single center study on AD patients exhibiting mild to moderate spleen and kidney deficiency, phlegm turbidity, and obstruction of the orifices. These patients were admitted to the outpatient department and treatment area of the Brain Disease Department at the Third Affiliated Clinical Hospital of Changchun University of Chinese Medicine. Following a comprehensive evaluation, the diagnosis of AD was confirmed. This study was conducted in accordance with the principles of the Helsinki Declaration. The practitioner declares that all procedures follow medical regulations and this study was evaluated and approved by the Ethics Committee of the Third Affiliated Clinical Hospital of Changchun University of Traditional Chinese Medicine. The study was designed based on the observation reports presented in the randomized controlled study of strengthening epidemiology (STROBE).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. 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mini-mental State Examination(MMSE)
timeFrame: 24 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 24 weeks
measure: Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog）
timeFrame: 24 weeks
measure: Clinical dementia rating(CDR)
timeFrame: 24 weeks
Secondary outcomes:
measure: Activity of daily living（ ADL ）
timeFrame: 24 weeks
measure: Hamilton Depression Stable （HAMD ）
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Changchun
country: China
facility: Changchun University of Traditional Chinese Medicine
state: Jilin
Study officials:
affiliation: Affiliated Hospital
name: Wei Zhang, Dr.
role: STUDY_DIRECTOR
References: