Mild Cognitive ImpairmentNCT04532697
Use of Gou-Teng to Treat Patients With Mild Cognitive Impairment
A study testing Uncaria Rhynchophylla (Gou-Teng) in people with Mild Cognitive Impairment and White Matter Hyperintensity, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment, White Matter Hyperintensity
- What is being tested?
- Uncaria Rhynchophylla (Gou-Teng)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Nov 2020to 25 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Uncaria Rhynchophylla (Gou-Teng), Placebo
- Keywords
- Gou-Teng, Mild Cognitive Impairment, White Matter Hyperintensities, ARIA
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Medicine | Active comparator | Uncaria Rhynchophylla (Gou-Teng) Receives: Other: Uncaria Rhynchophylla (Gou-Teng) |
| Placebo treatment | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (3)
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.
Measured: 16 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start24 Nov 2020
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will recruited in parallel.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhixiu Lin, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532697
- Sponsor's protocol ID
- MCI-Gou Teng study
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2020
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04532697
- Acronym / sponsor ID
- MCI-Gou Teng study
- Keywords
- Gou-Teng, Mild Cognitive Impairment, White Matter Hyperintensities, ARIA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All patients will recruited in parallel.
| Arm | Type | Receives |
|---|---|---|
| Chinese Medicine | Active comparator | Other: Uncaria Rhynchophylla (Gou-Teng)Uncaria Rhynchophylla (Gou-Teng) |
| Placebo treatment | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Chinese Medicine |
| PlaceboAll 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. | Other | Placebo treatment |
Primary outcome
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.
3 secondary outcomes
Automatic Retinal Image Analysis (ARIA)
Time frame: 16 weeks
HK-MoCA
Time frame: 24 weeks
Automatic Retinal Image Analysis (ARIA)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhixiu Lin, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uncaria Rhynchophylla (Gou-Teng) in people with Mild Cognitive Impairment and White Matter Hyperintensity, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HK-MoCA (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.