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Completed

NCT Number: NCT04532697

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders White Matter Hyperintensity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. HK-MoCA

    Time frame: 16 weeks

    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 outcomes

  1. Automatic Retinal Image Analysis (ARIA)

    Time frame: 16 weeks

    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.

  2. HK-MoCA

    Time frame: 24 weeks

    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.

  3. Automatic Retinal Image Analysis (ARIA)

    Time frame: 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2020
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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