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

NCT ID: NCT04532697

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-24
• Study Completion Date: 2022-09-30

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.

Conditions

Mild Cognitive Impairment; White Matter Hyperintensity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Chinese Medicine

Uncaria Rhynchophylla (Gou-Teng)

Group Type: ACTIVE_COMPARATOR

Uncaria Rhynchophylla (Gou-Teng)

Intervention Type: OTHER

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.

Placebo treatment

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

Uncaria Rhynchophylla (Gou-Teng)

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

Placebo

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

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Lin Zhixiu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhixiu Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Mei Kwan Lai

Role: CONTACT

athenalmk@cuhk.edu.hk

39433505

Facility Contacts

Cho Wing Lo, MSc

Role: primary

Other Identifiers

MCI-Gou Teng study

Identifier Type: -

Identifier Source: org_study_id