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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03221894
Recruitment Status : Unknown
Verified July 2017 by Jinzhou Tian, Dongzhimen Hospital, Beijing.
Recruitment status was:  Recruiting
First Posted : July 19, 2017
Last Update Posted : July 25, 2017
Beijing Hospital
Chinese PLA General Hospital
Peking University Third Hospital
Information provided by (Responsible Party):
Jinzhou Tian, 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.

Condition or disease Intervention/treatment
Alzheimer Disease Dietary Supplement: GRAPE granules

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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study to Investigate the Additive Effectiveness of Chinese Herbal Medicine in Alzheimer's Disease
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

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

Conventional therapy alone
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.

Primary Outcome Measures :
  1. Mini-Mental State Examination (MMSE) [ Time Frame: 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 :
  1. Activities of Daily Living (ADLs) [ Time Frame: 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.

  2. Clinical Dementia Rating (CDR) [ Time Frame: 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.

  3. Neuropsychiatric Inventory (NPI) [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
AD patients involved in this retrospective, observational study will be selected from the clinic registration system of memory clinics in Beijing. All the participants underwent routine clinical assessments, including detailed medical history, cognitive and neuropsychological tests, neurological examinations, laboratory tests (i.e. thyroid function, folic acid levels, vitamin B12 levels, and routine blood tests), and neuroimaging. Participants with detailed medical history will be sampled and grouped into two cohorts according the therapies received.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03221894

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Contact: Jinzhou TIAN, Dr 86-10-84013380
Contact: Jingnian NI, Dr 86-10-84013380

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Dongzhimen Hospital Recruiting
Beijing, China
Contact: Jing Shi, M.D.    86-10-84013132   
Sponsors and Collaborators
Dongzhimen Hospital, Beijing
Beijing Hospital
Chinese PLA General Hospital
Peking University Third Hospital
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Principal Investigator: Jinzhou TIAN, Dr Dongzhimen Hospital, BUCM

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Responsible Party: Jinzhou Tian, Prof., Dongzhimen Hospital, Beijing Identifier: NCT03221894     History of Changes
Other Study ID Numbers: 2017-IRT-0810
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The datasets are available from the PI on reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jinzhou Tian, Dongzhimen Hospital, Beijing:
Complementary therapies

Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders