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

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ClinicalTrials.gov 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
Sponsor:
Collaborators:
Beijing Hospital
Chinese PLA General Hospital
Peking University Third Hospital
Information provided by (Responsible Party):
Jinzhou Tian, Dongzhimen Hospital, Beijing

Tracking Information
First Submitted Date July 17, 2017
First Posted Date July 19, 2017
Last Update Posted Date July 25, 2017
Actual Study Start Date July 15, 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03221894 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 17, 2017)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Study to Investigate the Additive Effectiveness of Chinese Herbal Medicine in Alzheimer's Disease
Official Title A Retrospective Study to Investigate the Additive Effectiveness of Chinese Herbal Medicine in Alzheimer's Disease
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts
  • Conventional therapy with herbs
    Patients were treated with conventional therapy with Chinese herbal medicine (GRAPE granules).
    Intervention: Dietary Supplement: GRAPE granules
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 17, 2017)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03221894
Other Study ID Numbers 2017-IRT-0810
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: The datasets are available from the PI on reasonable request.
Responsible Party Jinzhou Tian, Dongzhimen Hospital, Beijing
Study Sponsor Dongzhimen Hospital, Beijing
Collaborators
  • Beijing Hospital
  • Chinese PLA General Hospital
  • Peking University Third Hospital
Investigators
Principal Investigator: Jinzhou TIAN, Dr Dongzhimen Hospital, BUCM
PRS Account Dongzhimen Hospital, Beijing
Verification Date July 2017