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

NCT04249869 | Unknown Phase 1 DMC

• 1 other identifier: V109C-129
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer Disease

Keywords

Chinese Herbal Medicine; Alzheimer's disease; Complementary Medicine

Outcome Measures

Primary Outcomes (5)

• Changes of Geriatric Depression Scale (GDS)

  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).

  week 0, 8, 10,18,22

• Changes of Mini-Mental State Examination (MMSE)

  Global cognition will be assessed by the MMSE,which will be conducted at baseline, week8, 10,18 and follow-up (22 weeks).

  week 0, 8, 10,18,22

• Changes of Neuropsychiatric Inventory(NPI-Q)

  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).

  week 0, 8, 10,18,22

• Changes of Instrumental Activities of Daily Living (IADL)

  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).

  week 0, 8, 10,18,22

• 5. Changes of The Informant Questionnaire on Cognitive Decline in the Elderly (Short-IQCODE)

  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.

  week 0, 8, 10,18,22

Secondary Outcomes (3)

• Changes of Quality of Life-Alzheimer's Disease (QOL-AD)

  week 0, 8, 10,18,22

• Changes of Constitution in Chinese Medicine Questionnaire (TCM50)

  week 0, 8, 10,18,22

• Chinese medicine adverse effect assessment

  week 0, 4, 8, 10, 14, 18, 22

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

PLACEBO COMPARATOR

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

Interventions

VGH-AD1 DRUG

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.

Group A; Group B

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged over 65 years old regardless of gender.
• Under the subject's and caregiver's willing and agreement.
• 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;
• MMSE score between 14 and 26;
• Under standard treatment regularly over 3 months. (Includes Acetylcholinesterase inhibitor, NMDA receptor antagonist, and antipsychotics, antidepressants, mood stabilizer, and anxiolytic agents)

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Related Publications (22)

• 2011 Taiwan Longitudinal Study on Aging Survey Report Health Promotion Administration, Ministry of Health and Welfare 2014.

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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

• Shinn-Jang Hwang, M.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shinn-Jang Hwang, M.D.

CONTACT

+886-2-28757686; sjhwang@vghtpe.gov.tw

Pei-Wen Wu, M.D.

CONTACT

+886-2-28757453; tcmpww@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share