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Guilingji Capsule for Mild-to-moderate Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT03647384
Recruitment Status : Active, not recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Collaborators:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing Xuanwu Traditional Chinese Medicine Hospital
Beijing Hospital
Beijing Shijitan Hospital
Peking University First Hospital
Huadong Hospital
Longhua Hospital
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Shandong University of Traditional Chinese Medicine
Shanxi Dayi Hospital
Shaanxi Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Li Hao, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cognitive Dysfunction Drug: Gulingji capsules Drug: Ginko Biloba Extract tablet Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Participants are randomly and evenly assigned to 2 groups using block randomization.Random numbers are generated by the stratified random method using the SAS statistical software and assigned by an independent statistician at the Good Clinical Practice Institute of Xiyuan Hospital. Drugs are numerically labeled and sequenced according to the random numbers. The drug randomization is conducted by drug supplier. The patients are assigned to the intervention according to the sequence.

The clinicians, patients and statistician are blind to the patients' grouping assignment and intervention. Database is locked after all data is inputted. The grouping information will be revealed when statistical analyses are conducted. The researchers reveal the second blinding and write the study report finally. Unblinding is allowed only in emergency situation for the patients

Primary Purpose: Other
Official Title: Efficacy and Safety of Guilingji Capsule in Older Adults With Mild-to-Moderate Cognitive Impairment (Kidney and Marrow Deficiency Pattern)
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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.
Drug: Gulingji capsules
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.

Active Comparator: Control
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.
Drug: Ginko Biloba Extract tablet
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 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.

  2. 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 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.

  3. 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 ADL is a test used in healthcare to evaluate the people's daily self care activities.

  4. 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 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.

  5. The Change From Baseline in The Serum Level of Acetylcholine and Acetylcholinesterase at Week 24 [ Time Frame: Baseline, 24th week±3 days ]
    Acetylcholine and acetylcholinesterase are potential circulatory biomarkers of cognitive dysfunction.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged between 60 and 85 years old
  2. With a disease course ≥ 6 months and confirmed by others
  3. Mini-Mental State Examination (MMSE) score between 10 and 26, or MMSE score >26 but Montreal Cognitive Assessment (MoCA) score<26
  4. Meeting the diagnostic criteria of mild-to-moderate cognitive impairment
  5. Meeting the diagnostic criteria of kidney deficiency pattern in Traditional Chinese medicine
  6. Screening visit brain MRI and CT scan consistent with the diagnosis of mild-to-moderate cognitive impairment
  7. Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments
  8. Received a primary and/or a higher education
  9. 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
  10. Signed and dated written informed consent. The subject's caregiver must also consent to participate in the study

Exclusion Criteria:

  1. 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
  2. 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
  3. Allergic to Ginkgo products
  4. Use of any other medications with the potential to affect cognition
  5. Current presence of a clinically important major psychiatric disorder or symptom
  6. Alcohol addiction, or long-term use of antipsychotic drugs, or a history of severe head trauma
  7. Cannot complete with cognitive function examines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647384


Locations
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China, Beijing
Li Hao
Beijing, Beijing, China, 100091
Sponsors and Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing Xuanwu Traditional Chinese Medicine Hospital
Beijing Hospital
Beijing Shijitan Hospital
Peking University First Hospital
Huadong Hospital
Longhua Hospital
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Shandong University of Traditional Chinese Medicine
Shanxi Dayi Hospital
Shaanxi Hospital of Traditional Chinese Medicine
Investigators
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Study Chair: Hao Li Institute of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences,

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Responsible Party: Li Hao, Study Chair, Xiyuan Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03647384     History of Changes
Other Study ID Numbers: 2018XLA039-2
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Li Hao, Xiyuan Hospital of China Academy of Chinese Medical Sciences:
Traditional Chinese medicine
Randomized clinical trial
Mild-to-moderate cognitive impairment

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders