Cognitive DysfunctionPhase 2NCT03647384
Guilingji Capsule for Mild-to-moderate Cognitive Impairment
A Phase 2 study testing Gulingji capsules and Ginko Biloba Extract tablet in people with Cognitive Dysfunction, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
This study is aiming to evaluate the efficacy and safety of Guilingji capsule in older adults with mild-to-moderate cognitive impairment who diagnosed as the kidney and marrow deficiency pattern in TCM. A total of 348 participants are evenly assigned to two arms. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Gulingji capsules and Ginko Biloba Extract tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2018to Dec 2019
- Phase
- Phase 2
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 60 and 85 years old
- With a disease course ≥ 6 months and confirmed by others
- Mini-Mental State Examination (MMSE) score between 10 and 26, or MMSE score >26 but Montreal Cognitive Assessment (MoCA) score<26
- Meeting the diagnostic criteria of mild-to-moderate cognitive impairment
- Meeting the diagnostic criteria of kidney deficiency pattern in Traditional Chinese medicine
- Screening visit brain MRI and CT scan consistent with the diagnosis of mild-to-moderate cognitive impairment
Show all 10Show fewer
- Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments
- Received a primary and/or a higher education
- Lives at home with appropriate caregiver capable of accompanying the subject on all clinic visits, or community dwelling with caregiver capable of accompanying the subject on all clinic visits and visiting with the subject approximately 5 times per week for the duration of the study
- Signed and dated written informed consent. The subject's caregiver must also consent to participate in the study
Who cannot join
- Significant neurological disease, other than AD MCI and VaD, that may affect cognition, such as the Parkinson's disease, the Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supra-nuclear palsy, epilepsy, chronic subdural hematoma and multiple sclerosis, history of severe head trauma with persistent neurological deficits or known abnormal brain structure
- Thyroid disease, vitamin B12 or folic acid deficiency, severe anemia or malnutrition, serious heart, liver, lung, kidney and other organ diseases that may affect the cognitive function
- Allergic to Ginkgo products
- Use of any other medications with the potential to affect cognition
- Current presence of a clinically important major psychiatric disorder or symptom
- Alcohol addiction, or long-term use of antipsychotic drugs, or a history of severe head trauma
- Cannot complete with cognitive function examines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Guilingji Capsule in Older Adults With Mild-to-Moderate Cognitive Impairment (Kidney and Marrow Deficiency Pattern)
This study is aiming to evaluate the efficacy and safety of Guilingji capsule in older adults with mild-to-moderate cognitive impairment who diagnosed as the kidney and marrow deficiency pattern in TCM. A total of 348 participants are evenly assigned to two arms. In the intervention arm, participants receive Guilingji capsule and Ginko Biloba Extract mimetic in combination, while the other arm will receive Ginko Biloba Extract tablet with Gulingji mimetic.
Read the detailed description
This study is a multi-center, randomized, positive control, noninferiority clinical trials. Experimental arm (174 cases) take 0.6 g of Gulingji capsules once a day and 19.2 mg of Ginko Biloba Extract mimetic three times a day. Active Comparator arm (174 cases) should take 0.6 g of Gulingji mimetic once a day and 19.2 mg of Ginko Biloba Extract tablet three times a day. The intervention lasted for 24 weeks. Clinical researchers, participants and statisticians are blinded to the treatment assignment throughout the study. Co-primary efficacy endpoints are change from baseline to week 12 and 24 in Mini-Mental State Examination score and Montreal Cognitive Assessment (MoCA) total score.Change from baseline to week 12 and 24 in Clinical Dementia Rating score, Alzheimer's Disease Assessment Scale-Cognitive subscale score, Activities of Daily Living, and Chinese Medicine Symptom Scale scoreare additional endpoints. Prespecified secondary biomarker endpoint is change from baseline in the serum level of acetylcholine and acetylcholinesterase at week 24.
- Conditions
- Cognitive Dysfunction
- Being tested
- Gulingji capsules, Ginko Biloba Extract tablet
- Keywords
- Traditional Chinese medicine, Randomized clinical trial, Mild-to-moderate cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gulingji capsulesDrug
Patients take 0.6g of Gulingji capsules, 2 hours before breakfast, served with light salt water once a day. Also an oral take of 19.2mg Ginko Biloba Extract mimetic three times a day. Treatment lasts for 24 weeks.
Ginko Biloba Extract tabletDrug
Patients take 0.6g of Gulingji mimetic, 2 hours before breakfast, served with light salt water once a day. Also an oral take of 19.2mg Ginko Biloba Extract tablet three times a day. Treatment lasts for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In this arm, patients take 0.6g of Gulingji capsules, 2 hours before breakfast, served with light salt water once a day. Also an oral take of 19.2mg Ginko Biloba Extract mimetic three times a day. Treatment lasts for 24 weeks. Receives: Drug: Gulingji capsules |
| Control | Active comparator | In this arm, patients take 0.6g of Gulingji mimetic, 2 hours before breakfast, served with light salt water once a day. Also an oral take of 19.2mg Ginko Biloba Extract tablet three times a day. Treatment lasts for 24 weeks. Receives: Drug: Ginko Biloba Extract tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Week 12 and 24
MMSE is a 30-point questionnaire and contains items assessing orientation, memory, attention and calculation, naming and visuospatial skills of patients.
Measured: Baseline,12th week±3 days, 24th week±3 days
The Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 12 and 24
MoCA is a 30-point questionnaire and evaluates orientation, executive function, language ability, short-term memory, attention and visuospatial ability.
Measured: Baseline,12th week±3 days, 24th week±3 days
Secondary outcomes (5)
The Change From Baseline in Clinical Dementia Rating (CDR) Total Score at Week 12 and 24
The CDR test is a numeric scale used to quantify the severity of symptoms of dementia. It sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the CDR interview. The CDR includes discussions with the participant and caregiver using a structured format. CDR total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.
Measured: Baseline,12th week±3 days, 24th week±3 days
The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score at Week 12 and 24
The ADAS-Cog is a multi-item, objective measure of cognitive function. Analysis of the ADAS-Cog for this study is based upon an 12 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, 11) comprehension, and 12) attention during the test. The ADAS-Cog ranged from 0 to 75 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.
Measured: Baseline,12th week±3 days, 24th week±3 days
The Change From Baseline in Activities of Daily Living (ADL) Total Score at Week 12 and 24
The ADL is a test used in healthcare to evaluate the people's daily self care activities.
Measured: Baseline,12th week±3 days, 24th week±3 days
The Change From Baseline in The Chinese Medicine Symptom Scale (CM-SS) Total Score at Week 12 and 24
The CM-SS is a tool, designed according to the Guiding Principles of Clinical Research on New Drugs of Traditional Chinese Medicine issued in 2002, to evaluate the effects of treatments on Traditional Chinese medicine patterns (here refers to kidney deficiency pattern). Scoring is mainly based on some typical TCM symptoms, such as tongue coating and pulse.
Measured: Baseline,12th week±3 days, 24th week±3 days
The Change From Baseline in The Serum Level of Acetylcholine and Acetylcholinesterase at Week 24
Acetylcholine and acetylcholinesterase are potential circulatory biomarkers of cognitive dysfunction.
Measured: Baseline, 24th week±3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start22 Aug 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing Xuanwu Traditional Chinese Medicine Hospital, Beijing Hospital, Beijing Shijitan Hospital, Capital Medical University, Peking University First Hospital, Huadong Hospital, Longhua Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Affiliated Hospital of Shandong University of TCM, Shanxi Dayi Hospital, Shaanxi Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Li Hao, Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Hao Li, Study chair, Institute of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647384
- Sponsor's protocol ID
- 2018XLA039-2
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu NY, Pei H, Liu MX, Liu LT, Fu CG, Li H, Chen KJ. Efficacy and Safety of Guilingji Capsules () for Treating Mild-to-Moderate Cognitive Impairment: Study Protocol for A Randomized, Double-Blind, Positive-Controlled, Multicenter and Noninferiority Trial. Chin J Integr Med. 2020 Aug;26(8):577-582. doi: 10.1007/s11655-020-2723-5. Epub 2020 Aug 5.
PubMed 32761337
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Guilingji Capsule in Older Adults With Mild-to-Moderate Cognitive Impairment (Kidney and Marrow Deficiency Pattern)
- ClinicalTrials.gov ID
- NCT03647384
- Acronym / sponsor ID
- 2018XLA039-2
- Conditions
- Cognitive Dysfunction
- Keywords
- Traditional Chinese medicine, Randomized clinical trial, Mild-to-moderate cognitive impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing Xuanwu Traditional Chinese Medicine Hospital, Beijing Hospital, Beijing Shijitan Hospital, Capital Medical University, Peking University First Hospital, Huadong Hospital, Longhua Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Affiliated Hospital of Shandong University of TCM, Shanxi Dayi Hospital, Shaanxi Hospital of Traditional Chinese Medicine
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Aug 2018 (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.
This study is aiming to evaluate the efficacy and safety of Guilingji capsule in older adults with mild-to-moderate cognitive impairment who diagnosed as the kidney and marrow deficiency pattern in TCM. A total of 348 participants are evenly assigned to two arms. In the intervention arm, participants receive Guilingji capsule and Ginko Biloba Extract mimetic in combination, while the other arm will receive Ginko Biloba Extract tablet with Gulingji mimetic.
Detailed description
This study is a multi-center, randomized, positive control, noninferiority clinical trials. Experimental arm (174 cases) take 0.6 g of Gulingji capsules once a day and 19.2 mg of Ginko Biloba Extract mimetic three times a day. Active Comparator arm (174 cases) should take 0.6 g of Gulingji mimetic once a day and 19.2 mg of Ginko Biloba Extract tablet three times a day. The intervention lasted for 24 weeks. Clinical researchers, participants and statisticians are blinded to the treatment assignment throughout the study. Co-primary efficacy endpoints are change from baseline to week 12 and 24 in Mini-Mental State Examination score and Montreal Cognitive Assessment (MoCA) total score.Change from baseline to week 12 and 24 in Clinical Dementia Rating score, Alzheimer's Disease Assessment Scale-Cognitive subscale score, Activities of Daily Living, and Chinese Medicine Symptom Scale scoreare additional endpoints. Prespecified secondary biomarker endpoint is change from baseline in the serum level of acetylcholine and acetylcholinesterase at week 24.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Gulingji capsulesIn this arm, patients take 0.6g of Gulingji capsules, 2 hours before breakfast, served with light salt water once a day. Also an oral take of 19.2mg Ginko Biloba Extract mimetic three times a day. Treatment lasts for 24 weeks. |
| Control | Active comparator | Drug: Ginko Biloba Extract tabletIn this arm, patients take 0.6g of Gulingji mimetic, 2 hours before breakfast, served with light salt water once a day. Also an oral take of 19.2mg Ginko Biloba Extract tablet three times a day. Treatment lasts for 24 weeks. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged between 60 and 85 years old
- With a disease course ≥ 6 months and confirmed by others
- Mini-Mental State Examination (MMSE) score between 10 and 26, or MMSE score >26 but Montreal Cognitive Assessment (MoCA) score<26
- Meeting the diagnostic criteria of mild-to-moderate cognitive impairment
- Meeting the diagnostic criteria of kidney deficiency pattern in Traditional Chinese medicine
Key exclusion criteria (7 listed)
- Significant neurological disease, other than AD MCI and VaD, that may affect cognition, such as the Parkinson's disease, the Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supra-nuclear palsy, epilepsy, chronic subdural hematoma and multiple sclerosis, history of severe head trauma with persistent neurological deficits or known abnormal brain structure
- Thyroid disease, vitamin B12 or folic acid deficiency, severe anemia or malnutrition, serious heart, liver, lung, kidney and other organ diseases that may affect the cognitive function
- Allergic to Ginkgo products
- Use of any other medications with the potential to affect cognition
- Current presence of a clinically important major psychiatric disorder or symptom
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 |
|---|---|---|
| Gulingji capsulesPatients take 0.6g of Gulingji capsules, 2 hours before breakfast, served with light salt water once a day. Also an oral take of 19.2mg Ginko Biloba Extract mimetic three times a day. Treatment lasts for 24 weeks. | Drug | Intervention |
| Ginko Biloba Extract tabletPatients take 0.6g of Gulingji mimetic, 2 hours before breakfast, served with light salt water once a day. Also an oral take of 19.2mg Ginko Biloba Extract tablet three times a day. Treatment lasts for 24 weeks. | Drug | Control |
Primary outcome
The Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Week 12 and 24
Time frame: Baseline,12th week±3 days, 24th week±3 days
MMSE is a 30-point questionnaire and contains items assessing orientation, memory, attention and calculation, naming and visuospatial skills of patients.
The Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 12 and 24
Time frame: Baseline,12th week±3 days, 24th week±3 days
MoCA is a 30-point questionnaire and evaluates orientation, executive function, language ability, short-term memory, attention and visuospatial ability.
5 secondary outcomes
The Change From Baseline in Clinical Dementia Rating (CDR) Total Score at Week 12 and 24
Time frame: Baseline,12th week±3 days, 24th week±3 days
The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score at Week 12 and 24
Time frame: Baseline,12th week±3 days, 24th week±3 days
The Change From Baseline in Activities of Daily Living (ADL) Total Score at Week 12 and 24
Time frame: Baseline,12th week±3 days, 24th week±3 days
The Change From Baseline in The Chinese Medicine Symptom Scale (CM-SS) Total Score at Week 12 and 24
Time frame: Baseline,12th week±3 days, 24th week±3 days
The Change From Baseline in The Serum Level of Acetylcholine and Acetylcholinesterase at Week 24
Time frame: Baseline, 24th week±3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Derived from this study: PubMed 32761337Liu NY, Pei H, Liu MX, Liu LT, Fu CG, Li H, Chen KJ. Efficacy and Safety of Guilingji Capsules () for Treating Mild-to-Moderate Cognitive Impairment: Study Protocol for A Randomized, Double-Blind, Positive-Controlled, Multicenter and Noninferiority Trial. Chin J Integr Med. 2020 Aug;26(8):577-582. doi: 10.1007/s11655-020-2723-5. Epub 2020 Aug 5.
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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.
Hao Li study chair
Institute of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gulingji capsules and Ginko Biloba Extract tablet in people with Cognitive Dysfunction, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Aug 2018. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Week 12 and 24 (time frame: Baseline,12th week±3 days, 24th week±3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03647384, which also lists 1 linked publication.
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 Aug 2018.