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A Retrospective Study to Investigate the Additive Effectiveness of Chinese Herbal Medicine in Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETED

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

NCT03221894•Dongzhimen Hospital, Beijing

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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.

Eligibility

Age

50 - 85 years

Sex

ALL

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).

Locations (1)

Dongzhimen Hospital

Beijing, China

Key Dates

Start Date

July 15, 2017

Primary Completion Date

July 31, 2021

Completion Date

July 31, 2021

Last Updated

August 20, 2021

Enrollment

120

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

GRAPE granules

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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