Clinical trial NCT03221894: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: Complementary therapies
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
name: Chinese PLA General Hospital
name: Peking University Third Hospital
First posted: 2017-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: Up to 12 months, repeated measurement every 3 months.
Secondary outcomes:
measure: Activities of Daily Living (ADLs)
timeFrame: Up to 12 months, repeated measurement every 3 months.
measure: Clinical Dementia Rating (CDR)
timeFrame: Up to 12 months, repeated measurement every 3 months.
measure: Neuropsychiatric Inventory (NPI)
timeFrame: Up to 12 months, repeated measurement every 3 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
Study officials:
affiliation: Dongzhimen Hospital, BUCM
name: Jinzhou TIAN, Dr
role: PRINCIPAL_INVESTIGATOR
References: