NCT03838952

Brief Summary

The Clinical trial is a pilot study for treatment of Alzheimer dementia by traditional Chinese herbal medicine(TCM).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

February 1, 2019

Last Update Submit

February 11, 2019

Conditions

DementiaAlzheimer Disease

Keywords

Chinese Herbal MedicineHerbal treatment

Outcome Measures

Primary Outcomes (4)

  • Changes of Mini-Mental State Examination(MMSE)

    Global cognition will be assessed by the MMSE,which will be conducted at baseline, 0weeks, 12weeks, and follow-up (16 weeks).

    week 0, 12, 16

  • 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 wil be conducted baseline, 12weeks, and follow-up (16 weeks)

    week 0, 12, 16

  • 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 NPI-Q will be conducted at baseline, 12 weeks, and follow-up (16 weeks).

    week 0, 12, 16

  • 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, 12weeks, and follow-up (16 weeks).

    week 0, 12, 16

Secondary Outcomes (3)

  • Blood test (AST/ALT/Serum Creatinine)

    week 0, 16

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

    week 0, 12, 16

  • Changes of Constitution in Chinese Medicine Questionnaire

    week 0, 12, 16

Study Arms (1)

Chinese herbal medicine group

EXPERIMENTAL

drug for the subjects

Drug: Herbal medicine

Interventions

Herbal medicineDRUG

Each pack: Jia Wei Xiao Yao San granule(5 gm), Gou Teng granule (1.1 gm),and Ba Ji Tian (1.1 gm), 2 times per day for 12 weeks.

Chinese herbal medicine group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • diagnosis of mild to moderate Alzheimer dementia;
  • aged over 65 years old in both gender;
  • MMSE score between 14 and 26;
  • adequate vision and hearing ability to complete all study tests;
  • with a stable caregiver.

You may not qualify if:

  • a medical history of other dementia types, like 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

DementiaAlzheimer Disease

Interventions

Phytotherapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

Fang-Pey Chen, MD

CONTACT

+886-2-2875-7453fpchen@vghtpe.gov.tw

Pei-Wen Wu, MD

CONTACT

+886-2-2875-7453tcmpww@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 12, 2019

Study Start

February 11, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations

TW(1)