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NCT04249869 | Unknown status | Alzheimer Disease


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

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

Alzheimer Disease

Intervention/treatment

VGH-AD1

Phase

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.

Study Type : Interventional
Estimated Enrollment : 28 participants
Masking: Triple
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
Actual 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

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

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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)
Exclusion Criteria
  • 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

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

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

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