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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221894
• Other study ID #: 2017-IRT-0810
• Status: Completed
• Start date: July 15, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: Dongzhimen Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Dietary Supplement:
• GRAPE granules
GRAPE granules was mainly consisted of herbal medicines: Ren Shen (Ginseng, 10g/d), Di Huang (Rehmannia glutinosa, 30g/d), Shi Cangpu (Acorus tatarinowii, 10g/d), Yuan Zhi (Polygala tenuifolia, 10g/d), Yin Yanghuo (Epimedium brevicornu, 10g/d), Shan Zhuyu (Cornus officinalis, 10g/d), Rou Congrong (Cistanche deserticola, 10g/d), Yu Jin (Curcuma aromatica, 10g/d), Dan Shen (Salvia miltiorrhiza, 10g/d), Tian Ma (Angelica sinensis, 10g/d), Tian ma (Gastrodia elata, 10g/d), and Huang Lian (Berberine, 10g/d), which were supplied by Beijing Tcmages Pharmaceutical Co., LTD, Each bag of granules with 150ml warm water melt was taken orally twice a day.

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Dongzhimen Hospital, Beijing	Beijing Hospital, Chinese PLA General Hospital, Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Mental State Examination (MMSE)	Change of global cognition was measured by MMSE, a 30-point scale, higher score indicates better cognition.	Up to 12 months, repeated measurement every 3 months.
Secondary	Activities of Daily Living (ADLs)	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.	Up to 12 months, repeated measurement every 3 months.
Secondary	Clinical Dementia Rating (CDR)	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.	Up to 12 months, repeated measurement every 3 months.
Secondary	Neuropsychiatric Inventory (NPI)	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.	Up to 12 months, repeated measurement every 3 months.