Exploratory clinical study of Compound Congrong Yizhi capsules in treating mild and moderate Alzheimer's disease
- Conditions
- Alzheimer's disease
- Registration Number
- ITMCTR2023000014
- Lead Sponsor
- The Affiliated Hospital of Qingdao University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Those who meet all the following items shall be included in this trial:
(1)Male or female, aged between 50 and 85 years at the time of Informed Consent Form signing.
(2)Patients must meet the probable Alzheimer's Disease criteria as defined by the National Institute on Aging-Alzheimer's Disease Association;
(3)At the screening visit, the Simple Mental Status Scale scored 17 for the illiterate group, 20 for the primary school group, 22 for the middle school group and 24 for the high school group.
(4)At screening, the total clinical dementia rating scale score is 2, and the memory frame score must be 0.5 to diagnose mild-to-moderate Alzheimer's Disease.
(5)Subjects will have a stable and reliable caregiver who will assist the participant in the study.
(6)With at least 5 years of education and the physical, cognitive, hearing, speech, literacy and language skills required to participate in all tests.
(7)Female patients were menopausal women (24 weeks) or surgical sterilization, or women of childbearing age agreed to effective contraception during the trial. Women of childbearing age or patients with menopause time of less than 24 weeks must have urine pregnancy experiments at screening, and the results must be negative.
(8)Informed consent forms, signed and dated by the patient (or her legal representative) and study partner, must be obtained prior to any study-related procedures.
(1)Patients with significant and/or current neurological disorders affecting cognition or study completion abilities, including but not limited to types of dementia other than Alzheimer's disease, repetitive brain trauma, severe brain infection, Parkinson's disease, epilepsy, or cerebrovascular diseases, are excluded from participation except for Alzheimer's disease.
(2)Patients with unstable or severe cardiac, pulmonary, hepatic, renal, or hematopoietic system diseases are excluded.
(3)Patients with contraindications for magnetic resonance imaging, such as implanted metallic materials or claustrophobia, and those who cannot complete neuropsychological tests and assessments due to other physical or mental illnesses are excluded.
(4)Patients who have participated in or are currently participating in other drug trials within the three months prior to enrollment are excluded.
(5)Patients with poor compliance, severe illness, or life-threatening conditions that prevent them from completing the treatment regimen are excluded.
(6)Patients who have used other cognitive enhancer drugs such as Cholinesterase Inhibitors or other psychotropic medications in the past three months are excluded.
(7)Patients with unstable psychiatric disorders or those diagnosed with psychiatric illnesses within the last 12 months as per the Diagnostic and Statistical Manual of Mental Disorders criteria, including schizophrenia or other psychiatric disorders, bipolar disorder, severe depression, or delirium, which may interfere with the study assessments, are excluded.
(8)Patients with a history of allergies to any component of Compound Cognition Capsules or Donepezil Hydrochloride Tablets are excluded.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Alzheimer's disease assessment scale;
- Secondary Outcome Measures
Name Time Method Clinicians' Interview-Based Impression Changescale;Activities of daily living;Mini-Mental State Examination;Clinical Dementia Rating;Imageological examination;Trail making test;Rey-Osterrieth complex figure;Traditional Chinese Medicine syndrome scale of senile brain health;Auditory Verbal Learning Test-Tatal;Auditory Verbal Learning Test;Plasma biomarker indicators;