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

Dongzhimen Hospital, Beijing

Status: Completed

Conditions: Alzheimer Disease

Treatments: Dietary Supplement: GRAPE granules

Study type: Observational

Funder types: Other

Identifiers

NCT03221894

2017-IRT-0810

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

120 participants in 2 patient groups

Conventional therapy with herbs

Description:

Patients were treated with conventional therapy with Chinese herbal medicine (GRAPE granules).

Treatment:

Dietary Supplement: GRAPE granules

Conventional therapy alone

Description:

In conventional therapy group, donepezil was the commonly used ChEI(cholinesterase inhibitor) to treat mild to severe AD patients. Memantine, a NMDA(N-methyl-D-aspartate ) antagonist, was given to moderate and severe AD patients. The dose of donepezil ranged from 5 to 10 mg once a day according to patients.