search
Back to results

Use of Gou-Teng to Treat Patients With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment, White Matter Hyperintensity

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Uncaria Rhynchophylla (Gou-Teng)
Placebo
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Gou-Teng, Mild Cognitive Impairment, White Matter Hyperintensities, ARIA

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both male and female individuals aged 65 years or over at their last birthday
  • Montreal Cognitive Assessment (Hong Kong version) (HK-MoCA) age/education matched percentile (score), with the cut off score of ≤16th percentile
  • Understand the questionnaires used in the study
  • Agreement to give informed consent

Exclusion Criteria:

  • Known dementia including Alzheimer's disease
  • Current drug use for the treatment of MCI or dementia
  • Patient Health Questionnaire-9 (PHQ-9) score 15 or more
  • Known psychiatric diseases such as depressive episode, bipolar disorder, obsessive-compulsive disorder and schizophrenia;
  • Known history of seizures;
  • Known history of stroke associated with permanent disability;
  • Known history of liver and renal impairment;
  • Known history of allergy to Chinese herbal medicine;
  • Concomitant use of warfarin or any anti-coagulants
  • Current history of hazardous or harmful alcohol consumption;
  • Current medical history that prevented participation in the study tasks such as sensory impairment and advanced cancer;
  • Current use of any kind of herbal medicine for the prevention and treatment of dementia.

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Chinese Medicine

Placebo treatment

Arm Description

Uncaria Rhynchophylla (Gou-Teng)

Placebo

Outcomes

Primary Outcome Measures

HK-MoCA
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. Scoring of HK MoCA ranges from 0 to 30 points. 3 cutoff percentile will be used: 2nd, 7th, and 16th percentile. The cut-off percentile at 16th above is considered normal and it shows worse with the decreasing percentile.

Secondary Outcome Measures

Automatic Retinal Image Analysis (ARIA)
White Matter Hyperintensities (WMH) is closely associated with multiple brain functions. It is an objective surrogate marker for MCI/dementia. The severity of WMH changes can be estimated by taking the fundus retinal image and put to the ARIA algorithm, the scale ranges from 0 to 3, increasing score means increasing severity.
HK-MoCA
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. Scoring of HK MoCA ranges from 0 to 30 points. 3 cutoff percentile will be used: 2nd, 7th, and 16th percentile. The cut-off percentile at 16th above is considered normal and it shows worse with the decreasing percentile.
Automatic Retinal Image Analysis (ARIA)
White Matter Hyperintensities (WMH) is closely associated with multiple brain functions. It is an objective surrogate marker for MCI/dementia. The severity of WMH changes can be estimated by taking the fundus retinal image and put to the ARIA algorithm, the scale ranges from 0 to 3, increasing score means increasing severity.

Full Information

First Posted
July 22, 2020
Last Updated
July 29, 2021
Sponsor
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT04532697
Brief Title
Use of Gou-Teng to Treat Patients With Mild Cognitive Impairment
Official Title
Efficacy of Uncaria Rhynchophylla (Gou-Teng) for Patients With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial Using White Matter Hyperintensities Estimated by ARIA as Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Mild cognitive impairment (MCI) is a pre-dementia condition commonly occurs in elderly people. As Hong Kong has become an aged society, the prevalence of dementia and MCI in Hong Kong has increased substantially in recent decades. To date, no effective pharmacological therapies are available for MCI, and there exists a need for exploring complementary treatment for this age-related condition. Preclinical studies have identified Uncaria rhynchophylla (Gouteng in Chinese) to have promising neuroprotective effect in Alzheimer's disease experimental models. Objective: To assess the effectiveness and the safety of oral administration of Uncaria rhynchophylla for MCI in older people in Hong Kong. Study design: This is a double-blinded, randomized, placebo controlled pilot study. 56 patients with MCI will be randomized into two groups i.e. Uncaria rhynchophylla and placebo groups. All subjects will receive treatment twice a day for a consecutive 16 weeks.
Detailed Description
It is hypothesized that U. rhynchophylla may have good therapeutic efficacy for the treatment of MCI. However, up to now, there exists no clinical data to support the use of U.rhynchophylla for MCI. To evaluate the efficacy of U. rhynchophylla for MCI, the investigator will use a fully automatic retinal image analysis (ARIA) method to estimate the WMH and use this as one of the outcome measures. The aim of this pilot study is to evaluate the effectiveness and safety of a Chinese herbal preparation U. rhynchophylla for subjects with mild cognitive impairment. It is hypothesized that treatment with U. rhynchophylla is able to significantly improve the cognitive function of subjects with MCI and reduce the white matter hyperintensities (WMH) in the brain of these subjects. All eligible subjects will be randomly assigned to receive a treatment of either Uncaria rhynchophylla or placebo for 16 weeks followed by 8 weeks observation. All subjects, both of the intervention and control group, will receive standard routine care from the conventional healthcare system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, White Matter Hyperintensity
Keywords
Gou-Teng, Mild Cognitive Impairment, White Matter Hyperintensities, ARIA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All patients will recruited in parallel.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All the participants, outcome assessors and the investigator are all masked, only the staff preparing the study product know the treatment arm.
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chinese Medicine
Arm Type
Active Comparator
Arm Description
Uncaria Rhynchophylla (Gou-Teng)
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Other
Intervention Name(s)
Uncaria Rhynchophylla (Gou-Teng)
Intervention Description
Uncaria Rhynchophylla (Gou-Teng) is a kind of Chinese Medicine. All eligible subjects will be randomly assigned to receive a treatment of either Uncaria Rhynchophylla or placebo for 16 weeks followed by 8 weeks observation. The patient will be asked to take 1.2 g of the granule in the morning and another 1.2 g in the evening.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
All eligible subjects will be randomly assigned to receive a treatment of either Uncaria Rhynchophylla or placebo for 16 weeks followed by 8 weeks observation. The patient will be asked to take 1.2 g of the granule in the morning and another 1.2 g in the evening.
Primary Outcome Measure Information:
Title
HK-MoCA
Description
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. Scoring of HK MoCA ranges from 0 to 30 points. 3 cutoff percentile will be used: 2nd, 7th, and 16th percentile. The cut-off percentile at 16th above is considered normal and it shows worse with the decreasing percentile.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Automatic Retinal Image Analysis (ARIA)
Description
White Matter Hyperintensities (WMH) is closely associated with multiple brain functions. It is an objective surrogate marker for MCI/dementia. The severity of WMH changes can be estimated by taking the fundus retinal image and put to the ARIA algorithm, the scale ranges from 0 to 3, increasing score means increasing severity.
Time Frame
16 weeks
Title
HK-MoCA
Description
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. Scoring of HK MoCA ranges from 0 to 30 points. 3 cutoff percentile will be used: 2nd, 7th, and 16th percentile. The cut-off percentile at 16th above is considered normal and it shows worse with the decreasing percentile.
Time Frame
24 weeks
Title
Automatic Retinal Image Analysis (ARIA)
Description
White Matter Hyperintensities (WMH) is closely associated with multiple brain functions. It is an objective surrogate marker for MCI/dementia. The severity of WMH changes can be estimated by taking the fundus retinal image and put to the ARIA algorithm, the scale ranges from 0 to 3, increasing score means increasing severity.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both male and female individuals aged 65 years or over at their last birthday Montreal Cognitive Assessment (Hong Kong version) (HK-MoCA) age/education matched percentile (score), with the cut off score of ≤16th percentile Understand the questionnaires used in the study Agreement to give informed consent Exclusion Criteria: Known dementia including Alzheimer's disease Current drug use for the treatment of MCI or dementia Patient Health Questionnaire-9 (PHQ-9) score 15 or more Known psychiatric diseases such as depressive episode, bipolar disorder, obsessive-compulsive disorder and schizophrenia; Known history of seizures; Known history of stroke associated with permanent disability; Known history of liver and renal impairment; Known history of allergy to Chinese herbal medicine; Concomitant use of warfarin or any anti-coagulants Current history of hazardous or harmful alcohol consumption; Current medical history that prevented participation in the study tasks such as sensory impairment and advanced cancer; Current use of any kind of herbal medicine for the prevention and treatment of dementia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei Kwan Lai
Phone
39433505
Email
athenalmk@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhixiu Lin, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cho Wing Lo, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Gou-Teng to Treat Patients With Mild Cognitive Impairment

We'll reach out to this number within 24 hrs