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

NCT03221894 | Completed

• 1 other identifier: 2017-IRT-0810
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Complementary therapies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Activities of Daily Living (ADLs)

  Up to 12 months, repeated measurement every 3 months.

• Clinical Dementia Rating (CDR)

  Up to 12 months, repeated measurement every 3 months.

• Neuropsychiatric Inventory (NPI)

  Up to 12 months, repeated measurement every 3 months.

Study Arms (2)

Conventional therapy with herbs

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

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.

Interventions

GRAPE granules DIETARY_SUPPLEMENT

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 with herbs

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead
• Beijing Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Peking University Third Hospital: collaborator

Study Sites (1)

Dongzhimen Hospital

Beijing, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jinzhou TIAN, Dr

  Dongzhimen Hospital, BUCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 19, 2017
• Study Start: July 15, 2017
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

CN (1)