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

NCT04532697 | Unknown

• 1 other identifier: MCI-Gou Teng study
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; White Matter Hyperintensity

Keywords

Gou-Teng; Mild Cognitive Impairment; White Matter Hyperintensities; ARIA

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (3)

• Automatic Retinal Image Analysis (ARIA)

  16 weeks

• HK-MoCA

  24 weeks

• Automatic Retinal Image Analysis (ARIA)

  24 weeks

Study Arms (2)

Chinese Medicine

ACTIVE COMPARATOR

Uncaria Rhynchophylla (Gou-Teng)

Other: Uncaria Rhynchophylla (Gou-Teng)

Placebo treatment

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Uncaria Rhynchophylla (Gou-Teng) 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.

Chinese Medicine

Placebo 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.

Placebo treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Uncaria rhynchophylla

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Zhixiu Lin, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Kwan Lai

CONTACT

39433505; athenalmk@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All the participants, outcome assessors and the investigator are all masked, only the staff preparing the study product know the treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All patients will recruited in parallel.

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 31, 2020
• Study Start: November 24, 2020
• Primary Completion: March 31, 2022
• Study Completion: September 30, 2022
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)