Clinical trial NCT04249869: The Efficacy of Traditional Chinese Herbal Medicine for Alzheimer's Disease
Official title: The Effect of Traditional Chinese Medicine (VGH-AD1) on Patients With Alzheimer's Disease: A Double-blinded Randomized Placebo-controlled Cross-over Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Alzheimer Disease
Keywords: Chinese Herbal Medicine
Alzheimer's disease
Complementary Medicine
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-01-31
Enrollment: 28
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 28 participants will be recruited from the Division of Psychiatry and Neurology in a Medical Center. They will be randomized allocated into treatment and control groups, each including 14 participants. After eight weeks of taking, there is two-weeks of wash-out period. And then two groups will be switched for another eight weeks. Post-study follow up will be 4 weeks later once the intervention end. The study duration is totally 22 weeks.
Primary purpose: TREATMENT

Brief summary: This randomized, double-blinded, placebo-controlled, crossover clinical trial aims to investigate the effect of VGH-AD1, a scientific Chinese medicine powder prescription, on patients with Alzheimer's disease.

Detailed description: Dementia is a chronic, progressive neurodegenerative syndrome, characterized by an abroad category of non-reversible impairment in cerebral function, making a long-term and gradual decrease in the ability to mental cognitive tasks and performance of daily activities. The World Health Organization says that 47.5 million people around the world are living with dementia. Alzheimer's disease is accounting for 60-70 percent, the most common type of dementia. According to the record from the Ministry of Health and welfare in Taiwan, the population over 65-year-old is more than 3.36 million. It is estimated that there are more than 250,000 people with mental disabilities and nearly 600,000 people with mild cognitive impairment. With the aging of the population, experts predict that the number of patients suffering from Alzheimer's disease will be up to 800,000. In 2016, a study based on the health insurance database from 1997 to 2008 in Taiwan showed that 78.2 percent of patients have received Chinese medicine treatment, such as herbal medicine and acupuncture after diagnosed as Alzheimer's disease. Therefore, this clinical trial is designed as a randomized, double-blinded, placebo-controlled, crossover clinical trial that aims to investigate the effect of VGH-AD1, traditional Chinese herbal medicine powder, on Alzheimer's disease. Participants will be randomized allocated 14 participants into each group A and B. Group A will receive VGH-AD1, while group B will receive a placebo two times per day for eight weeks. Then entry two weeks wash-out period. And then two groups will be switched for another eight weeks. Post-study follow up will be 4 weeks after the intervention end. The study duration is totally 22 weeks. All participants will be assessed by the MMSE, IADL, NPI-Q, IQCODE, GDS, QOL-AD, TCM50, which will be conducted at baseline, week 8,10,18 and 22.

Eligibility criteria: Inclusion Criteria:

1. Aged over 65 years old regardless of gender.
2. Under the subject's and caregiver's willing and agreement.
3. According to DSM5 (American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing), was diagnosis of mild to moderate Alzheimer's type dementia;
4. MMSE score between 14 and 26;
5. Under standard treatment regularly over 3 months. (Includes Acetylcholinesterase inhibitor, NMDA receptor antagonist, and antipsychotics, antidepressants, mood stabilizer, and anxiolytic agents)

Exclusion Criteria:

1. Other types of dementia, such as Frontotemporal dementia, Dementia with Lewy Bodies, Vascular Dementia, and mixed type, et al;
2. Known of other neurological diseases, cranial nervous system cancer
3. Severe liver or kidney dysfunction (alanine aminotransferase\>200 IU/L, aspartate transaminase\>200 IU/L or serum creatinine \>2.5 mg/dl);
4. Severe cardiovascular disease (heart failure, coronary heart disease

Primary outcomes:
measure: Changes of Geriatric Depression Scale (GDS)
timeFrame: week 0, 8, 10,18,22
measure: Changes of Mini-Mental State Examination (MMSE)
timeFrame: week 0, 8, 10,18,22
measure: Changes of Neuropsychiatric Inventory(NPI-Q)
timeFrame: week 0, 8, 10,18,22
measure: Changes of Instrumental Activities of Daily Living (IADL)
timeFrame: week 0, 8, 10,18,22
measure: 5. Changes of The Informant Questionnaire on Cognitive Decline in the Elderly (Short-IQCODE)
timeFrame: week 0, 8, 10,18,22
Secondary outcomes:
measure: Changes of Quality of Life-Alzheimer's Disease (QOL-AD)
timeFrame: week 0, 8, 10,18,22
measure: Changes of Constitution in Chinese Medicine Questionnaire (TCM50)
timeFrame: week 0, 8, 10,18,22
measure: Chinese medicine adverse effect assessment
timeFrame: week 0, 4, 8, 10, 14, 18, 22
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Shinn-Jang Hwang, M.D.
role: PRINCIPAL_INVESTIGATOR
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