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Guilingji Capsule for Mild-to-moderate Cognitive Impairment

Primary Purpose

Cognitive Dysfunction

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gulingji capsules
Ginko Biloba Extract tablet
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cognitive Dysfunction focused on measuring Traditional Chinese medicine, Randomized clinical trial, Mild-to-moderate cognitive impairment

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Li Hao

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
August 23, 2018
Last Updated
August 23, 2018
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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, Shandong University of Traditional Chinese Medicine, Shanxi Dayi Hospital, Shaanxi Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03647384
Brief Title
Guilingji Capsule for Mild-to-moderate Cognitive Impairment
Official Title
Efficacy and Safety of Guilingji Capsule in Older Adults With Mild-to-Moderate Cognitive Impairment (Kidney and Marrow Deficiency Pattern)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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, Shandong University of Traditional Chinese Medicine, Shanxi Dayi Hospital, Shaanxi Hospital of Traditional Chinese Medicine

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction
Keywords
Traditional Chinese medicine, Randomized clinical trial, Mild-to-moderate cognitive impairment

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
348 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gulingji capsules
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ginko Biloba Extract tablet
Intervention Description
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 Measure Information:
Title
The Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Week 12 and 24
Description
MMSE is a 30-point questionnaire and contains items assessing orientation, memory, attention and calculation, naming and visuospatial skills of patients.
Time Frame
Baseline,12th week±3 days, 24th week±3 days
Title
The Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 12 and 24
Description
MoCA is a 30-point questionnaire and evaluates orientation, executive function, language ability, short-term memory, attention and visuospatial ability.
Time Frame
Baseline,12th week±3 days, 24th week±3 days
Secondary Outcome Measure Information:
Title
The Change From Baseline in Clinical Dementia Rating (CDR) Total Score at Week 12 and 24
Description
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.
Time Frame
Baseline,12th week±3 days, 24th week±3 days
Title
The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score at Week 12 and 24
Description
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.
Time Frame
Baseline,12th week±3 days, 24th week±3 days
Title
The Change From Baseline in Activities of Daily Living (ADL) Total Score at Week 12 and 24
Description
The ADL is a test used in healthcare to evaluate the people's daily self care activities.
Time Frame
Baseline,12th week±3 days, 24th week±3 days
Title
The Change From Baseline in The Chinese Medicine Symptom Scale (CM-SS) Total Score at Week 12 and 24
Description
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.
Time Frame
Baseline,12th week±3 days, 24th week±3 days
Title
The Change From Baseline in The Serum Level of Acetylcholine and Acetylcholinesterase at Week 24
Description
Acetylcholine and acetylcholinesterase are potential circulatory biomarkers of cognitive dysfunction.
Time Frame
Baseline, 24th week±3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Li
Organizational Affiliation
Institute of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences,
Official's Role
Study Chair
Facility Information:
Facility Name
Li Hao
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32761337
Citation
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.
Results Reference
derived

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Guilingji Capsule for Mild-to-moderate Cognitive Impairment

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