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The Efficacy of Traditional Chinese Herbal Medicine for Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT04249869
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: VGH-AD1 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Placebo is manufactured to have the same appearance as VGH-AD1. Both VGH-AD1 and placebo will be coded as packages A and B by the manufacturer and the codes will only be revealed after the study ends. Therefore, patients and investigators will both be blinded.
Primary Purpose: Treatment
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
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Group A
Group A will receive VGH-AD1 two times per day for 8 weeks, then entry 2 weeks wash-out period. Then switch to receive the placebo for another 8 weeks. Post-follow up will be 4 weeks later.
Drug: VGH-AD1
VGH-AD1 includes Yi-gan-san 3.0g, Huan-shao-dan 1.0g, Danshen(Radix et Rhizoma Salviae Miltiorrhizae) 0.75g, Tian-ma(Rhizoma Gastrodiae) 0.75g, Gou-teng(Ramulus Uncariae Cum Uneis) 0.375g, and Ba-ji-tian(Radix Morindae Officinalis) 0.375g, two times per day, each serving a small packet of 7.5 grams of concentrated granules.

Placebo Comparator: Group B
Group B will receive placebo two times per day for 8 weeks, then entry 2 weeks wash-out period. Then switch to receive the VGH-AD1 for another 8 weeks. Post-follow up will be 4 weeks later.
Drug: VGH-AD1
VGH-AD1 includes Yi-gan-san 3.0g, Huan-shao-dan 1.0g, Danshen(Radix et Rhizoma Salviae Miltiorrhizae) 0.75g, Tian-ma(Rhizoma Gastrodiae) 0.75g, Gou-teng(Ramulus Uncariae Cum Uneis) 0.375g, and Ba-ji-tian(Radix Morindae Officinalis) 0.375g, two times per day, each serving a small packet of 7.5 grams of concentrated granules.




Primary Outcome Measures :
  1. Changes of Geriatric Depression Scale (GDS) [ Time Frame: week 0, 8, 10,18,22 ]
    The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly, which will be conducted at baseline, week8, 10,18 and follow-up (22 weeks).

  2. Changes of Mini-Mental State Examination (MMSE) [ Time Frame: week 0, 8, 10,18,22 ]
    Global cognition will be assessed by the MMSE,which will be conducted at baseline, week8, 10,18 and follow-up (22 weeks).

  3. Changes of Neuropsychiatric Inventory(NPI-Q) [ Time Frame: week 0, 8, 10,18,22 ]
    The Neuropsychiatric Inventory Questionnaire (NPI-Q) is an informant-based instrument that measures the presence and severity of 12 Neuropsychiatric Symptoms (NPS) in patients with dementia, as well as informant distress. The NPIQ will be conducted at baseline, week 8, 10,18 and follow-up (22 weeks).

  4. Changes of Instrumental Activities of Daily Living (IADL) [ Time Frame: week 0, 8, 10,18,22 ]
    The instrumental activities of daily living (IADL) contains 8 items, such as shopping, cooking, doing laundry, handling finances, using telephone, mode of transportation, responsibility for own medication and housekeeping. The IADL will be conducted baseline, week 8, 10,18 and follow-up (22 weeks).

  5. 5. Changes of The Informant Questionnaire on Cognitive Decline in the Elderly (Short-IQCODE) [ Time Frame: week 0, 8, 10,18,22 ]
    The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) provides ratings of an individual's changes in everyday cognitive functions during the previous 10 years. The questionnaire contains a total 26 questions with scores 0 to 5. The item includes short-term memory, living skills, writing, house chores, and financial dealing. If the performance remains the same as 10 years ago, then rate 3. If the performance is much worsened compare 10 years ago, then rate 5; oppositely rate 1.


Secondary Outcome Measures :
  1. Changes of Quality of Life-Alzheimer's Disease (QOL-AD) [ Time Frame: week 0, 8, 10,18,22 ]
    The Quality of Life-Alzheimer's Disease (QOL-AD) has 13-items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole. The QOL-AD uses straightforward language for simplicity, which will be conducted at baseline, 8, 10,18 and follow-up (22 weeks).

  2. Changes of Constitution in Chinese Medicine Questionnaire (TCM50) [ Time Frame: week 0, 8, 10,18,22 ]
    The Constitution in Chinese Medicine Questionnaire (TCM50) consists of 60 items to classify a person into one or more of nine Body constitution(BC) types: gentleness (8 Items), Qi-deficiency (8 Items), Yang-deficiency (7 Items), Yin-deficiency (8 Items), phlegm-wetness (8 Items), wetness-heat (6 Items), blood-stasis (7 Items), Qi-depression (7 Items), and special diathesis (7 Items). Coexistence of multiple imbalanced BC types was possible which is consistent with the TCM theories. The scoring algorithm proposed in the original CCMQ was adopted in this study. A higher score in the CCMQ BC scale indicates a higher likelihood of the specific BC type, and a score of 30 is set as threshold for case definition. The CCMQ will be conducted at baseline, 8, 10,18 and follow-up (22 weeks).

  3. Chinese medicine adverse effect assessment [ Time Frame: week 0, 4, 8, 10, 14, 18, 22 ]
    In order to cautiously evaluate and monitor the safety of Chinese medicine, the adverse effect assessment form should be filled each time the subject visits.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 ClinicalTrials.gov identifier (NCT number): NCT04249869


Contacts
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Contact: Shinn-Jang Hwang, M.D. +886-2-28757686 sjhwang@vghtpe.gov.tw
Contact: Pei-Wen Wu, M.D. +886-2-28757453 tcmpww@gmail.com

Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Shinn-Jang Hwang, M.D. Taipei Veterans General Hospital, Taiwan
Publications:
2011 Taiwan Longitudinal Study on Aging Survey Report Health Promotion Administration, Ministry of Health and Welfare 2014.

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04249869    
Other Study ID Numbers: V109C-129
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Taipei Veterans General Hospital, Taiwan:
Chinese Herbal Medicine
Alzheimer's disease
Complementary Medicine
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders