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Alzheimer DiseasePhase 1/2NCT04249869

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

A Phase 1/2 study testing VGH-AD1 in people with Alzheimer Disease, run by Taipei Veterans General Hospital, Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
VGH-AD1
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
No sites listed yet
Study dates
1 Feb 2020to 31 Dec 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

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

About this study

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

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.

Read the 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.

Being tested
VGH-AD1
Keywords
Chinese Herbal Medicine, Alzheimer's disease, Complementary Medicine
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VGH-AD1Drug

    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.

Study groups in NCT04249869
Study groupRoleWhat they receive
Group AExperimentalGroup 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.
Receives: Drug: VGH-AD1
Group BPlacebo comparatorGroup 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.
Receives: Drug: VGH-AD1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: week 0, 8, 10,18,22

  2. 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).

    Measured: week 0, 8, 10,18,22

  3. 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).

    Measured: week 0, 8, 10,18,22

  4. 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).

    Measured: week 0, 8, 10,18,22

  5. 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.

    Measured: week 0, 8, 10,18,22

Secondary outcomes (3)

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

    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).

    Measured: week 0, 8, 10,18,22

  2. Changes of Constitution in Chinese Medicine Questionnaire (TCM50)

    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).

    Measured: week 0, 8, 10,18,22

  3. Chinese medicine adverse effect assessment

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2020
  2. Study start1 Feb 2020 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Participant, Care provider, Investigator
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04249869
Sponsor's protocol ID
V109C-129
Status last verified
Jan 2020
First submitted
29 Jan 2020
Last updated
31 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • Albert MS, Blacker D. Mild cognitive impairment and dementia. Annu Rev Clin Psychol. 2006;2:379-88. doi: 10.1146/annurev.clinpsy.1.102803.144039.

    PubMed 17716075

  • Chen TB, Yiao SY, Sun Y, Lee HJ, Yang SC, Chiu MJ, Chen TF, Lin KN, Tang LY, Lin CC, Wang PN. Comorbidity and dementia: A nationwide survey in Taiwan. PLoS One. 2017 Apr 12;12(4):e0175475. doi: 10.1371/journal.pone.0175475. eCollection 2017.

    PubMed 28403222

  • Shen CY, Jiang JG, Yang L, Wang DW, Zhu W. Anti-ageing active ingredients from herbs and nutraceuticals used in traditional Chinese medicine: pharmacological mechanisms and implications for drug discovery. Br J Pharmacol. 2017 Jun;174(11):1395-1425. doi: 10.1111/bph.13631. Epub 2016 Oct 29.

    PubMed 27659301

  • Shanthi KB, Krishnan S, Rani P. A systematic review and meta-analysis of plasma amyloid 1-42 and tau as biomarkers for Alzheimer's disease. SAGE Open Med. 2015 Aug 10;3:2050312115598250. doi: 10.1177/2050312115598250. eCollection 2015.

    PubMed 26770797

  • Shekhar S, Kumar R, Rai N, Kumar V, Singh K, Upadhyay AD, Tripathi M, Dwivedi S, Dey AB, Dey S. Estimation of Tau and Phosphorylated Tau181 in Serum of Alzheimer's Disease and Mild Cognitive Impairment Patients. PLoS One. 2016 Jul 26;11(7):e0159099. doi: 10.1371/journal.pone.0159099. eCollection 2016.

    PubMed 27459603

  • Zhang A, Sun H, Wang P, Han Y, Wang X. Future perspectives of personalized medicine in traditional Chinese medicine: a systems biology approach. Complement Ther Med. 2012 Feb-Apr;20(1-2):93-9. doi: 10.1016/j.ctim.2011.10.007. Epub 2011 Nov 30.

    PubMed 22305254

  • Li L, Zhang L, Yang CC. Multi-Target Strategy and Experimental Studies of Traditional Chinese Medicine for Alzheimer's Disease Therapy. Curr Top Med Chem. 2016;16(5):537-48. doi: 10.2174/1568026615666150813144003.

    PubMed 26268330

  • Lin SK, Yan SH, Lai JN, Tsai TH. Patterns of Chinese medicine use in prescriptions for treating Alzheimer's disease in Taiwan. Chin Med. 2016 Mar 28;11:12. doi: 10.1186/s13020-016-0086-9. eCollection 2016.

    PubMed 27028311

  • Chen KH, Yeh MH, Livneh H, Chen BC, Lin IH, Lu MC, Tsai TY, Yeh CC. Association of traditional Chinese medicine therapy and the risk of dementia in patients with hypertension: a nationwide population-based cohort study. BMC Complement Altern Med. 2017 Mar 29;17(1):178. doi: 10.1186/s12906-017-1677-4.

    PubMed 28356117

  • Ho YS, So KF, Chang RC. Drug discovery from Chinese medicine against neurodegeneration in Alzheimer's and vascular dementia. Chin Med. 2011 Apr 22;6:15. doi: 10.1186/1749-8546-6-15.

    PubMed 21513513

  • Chen D, Yang X, Yang J, Lai G, Yong T, Tang X, Shuai O, Zhou G, Xie Y, Wu Q. Prebiotic Effect of Fructooligosaccharides from Morinda officinalis on Alzheimer's Disease in Rodent Models by Targeting the Microbiota-Gut-Brain Axis. Front Aging Neurosci. 2017 Dec 8;9:403. doi: 10.3389/fnagi.2017.00403. eCollection 2017.

    PubMed 29276488

  • Ma X, Tan C, Zhu D, Gang DR, Xiao P. Huperzine A from Huperzia species--an ethnopharmacolgical review. J Ethnopharmacol. 2007 Aug 15;113(1):15-34. doi: 10.1016/j.jep.2007.05.030. Epub 2007 Jun 2.

    PubMed 17644292

  • Iwasaki K, Satoh-Nakagawa T, Maruyama M, Monma Y, Nemoto M, Tomita N, Tanji H, Fujiwara H, Seki T, Fujii M, Arai H, Sasaki H. A randomized, observer-blind, controlled trial of the traditional Chinese medicine Yi-Gan San for improvement of behavioral and psychological symptoms and activities of daily living in dementia patients. J Clin Psychiatry. 2005 Feb;66(2):248-52. doi: 10.4088/jcp.v66n0214.

    PubMed 15705012

  • Mizukami K, Asada T, Kinoshita T, Tanaka K, Sonohara K, Nakai R, Yamaguchi K, Hanyu H, Kanaya K, Takao T, Okada M, Kudo S, Kotoku H, Iwakiri M, Kurita H, Miyamura T, Kawasaki Y, Omori K, Shiozaki K, Odawara T, Suzuki T, Yamada S, Nakamura Y, Toba K. A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia. Int J Neuropsychopharmacol. 2009 Mar;12(2):191-9. doi: 10.1017/S146114570800970X. Epub 2008 Dec 11.

    PubMed 19079814

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VGH-AD1 in people with Alzheimer Disease, run by Taipei Veterans General Hospital, Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shinn-Jang Hwang, M.D. (+886-2-28757686, sjhwang@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of Geriatric Depression Scale (GDS) (time frame: week 0, 8, 10,18,22). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04249869, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.

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