A Retrospective Study to Investigate the Additive Effectiveness of Chinese Herbal Medicine in Alzheimer's Disease

Completed

• Conditions: Alzheimer Disease
• Interventions: Dietary Supplement: GRAPE granules

• Registration Number: NCT03221894
• Lead Sponsor: Dongzhimen Hospital, Beijing

Brief Summary

In China, herbal therapy as a complementary therapy is very popular. Should conventional therapy (such as donepezil and memantine) combined with herbal therapy make add-on benefit? Cognition, activities of daily living and behavioral symptoms will be assessed. Data will be collected from the medical records of patients with Alzheimer's disease (AD) in memory clinics.

Detailed Description

Conventional therapy (CT), such as donepezil and memantine are well- known short-term treatments for the symptoms of Alzheimer's disease (AD). The efficacy of them, however, drops below baseline level after 9 months. Should Chinese herbal medicine make add-on benefit? The GRAPE formula was designed by Prof. J Tian, a prepared granules of Chinese herbs, according to Qifuyin in Jing Yue Quan Shu (published in A.D. 1624). Patients treated with CT+herbal therapy or CT alone for up to and over 12 months are collected. Cognition, activities of daily living and behavioral symptoms are selected as outcomes for assessing the effectiveness.

Study Timeline

• Study Start: 2017-07-15
• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-17
• Study First Posted: 2017-07-19
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Gradual and progressive change in cognitive functions for a period greater than 6 months;
• Objective evidence of significantly impaired episodic memory together with at least one of other cognitive domains on testing;
• Global cognitive decline measured by mini-mental state examination (MMSE) adjusted for education: ≤22 for illiteracy, ≤23 for primary school, ≤24 for middle school,≤26 for high education;
• Impaired abilities of daily living, ADLs score ≥16;
• Clinical Dementia Rating (CDR) total score 0.5~3.0;
• ≤4 point on Hachinski Ischaemic Score (HIS);
• Age-adjusted medial temporal lobe atrophy scale (MTA-scale) based on coronary magnetic resonance imaging (MRI) scan of the brain (1.0 or more for ≤65 years; 1.5 or more for ≤75 years and 2.0 or more for ≥75 years);
• Other causes of dementia excluded.

Exclusion Criteria

• Sudden onset of cognitive disorder with focal nervous system signs in the early stages of disease, (e.g., incomplete paralysis, anesthesia, dysfunctional visual field, and dystaxia);
• Early occurrence of the following symptoms: gait disturbances, seizures, extrapyramidal signs, hallucinations and cognitive fluctuations;
• Any major psychiatric disorders (e.g., DSM-IV(Diagnostic and Statistical Manual of Mental Disorders) defined psychosis, major depression, bipolar disorder, or alcohol or substance abuse);
• Other conditions that may explain cognitive impairment (e.g., hypothyroidism, electrolyte imbalance, toxic, inflammatory, and metabolic disorders).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional therapy with herbs	GRAPE granules	Patients were treated with conventional therapy with Chinese herbal medicine (GRAPE granules).

Primary Outcome Measures

Name	Time	Method
Mini-Mental State Examination (MMSE)	Up to 12 months, repeated measurement every 3 months.	Change of global cognition was measured by MMSE, a 30-point scale, higher score indicates better cognition.

Secondary Outcome Measures

Name	Time	Method
Neuropsychiatric Inventory (NPI)	Up to 12 months, repeated measurement every 3 months.	NPI was used for rating the behavioral and psychological symptoms of dementia (BPSD), including 12-items, with a score rang from 0-144, higher score indicates worse state.
Clinical Dementia Rating (CDR)	Up to 12 months, repeated measurement every 3 months.	The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias. 0 = Normal, 0.5 = Very Mild Dementia, 1 = Mild Dementia, 2 = Moderate Dementia, 3 = Severe Dementia.
Activities of Daily Living (ADLs)	Up to 12 months, repeated measurement every 3 months.	Both basic ADLs (6-items) and instrumental ADLs (8-items) were measured. The ADLs contain 14 items (score 1-4), the range is 14 to 56, and higher scores indicate worse function.

Trial Locations

Locations (1)

Dongzhimen Hospital; 🇨🇳 Beijing, China