Clinical trial NCT03647384: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cognitive Dysfunction
Keywords: Traditional Chinese medicine
Randomized clinical trial
Mild-to-moderate cognitive impairment
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Beijing Xuanwu Traditional Chinese Medicine Hospital
name: Beijing Hospital
name: Beijing Shijitan Hospital, Capital Medical University
name: Peking University First Hospital
name: Huadong Hospital
name: Longhua Hospital
name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Shandong University of Traditional Chinese Medicine
name: Shanxi Dayi Hospital
name: Shaanxi Hospital of Traditional Chinese Medicine
First posted: 2018-08-27
Enrollment: 348
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: The Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Week 12 and 24
timeFrame: Baseline,12th week±3 days, 24th week±3 days
measure: The Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 12 and 24
timeFrame: Baseline,12th week±3 days, 24th week±3 days
Secondary outcomes:
measure: The Change From Baseline in Clinical Dementia Rating (CDR) Total Score at Week 12 and 24
timeFrame: Baseline,12th week±3 days, 24th week±3 days
measure: The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score at Week 12 and 24
timeFrame: Baseline,12th week±3 days, 24th week±3 days
measure: The Change From Baseline in Activities of Daily Living (ADL) Total Score at Week 12 and 24
timeFrame: Baseline,12th week±3 days, 24th week±3 days
measure: The Change From Baseline in The Chinese Medicine Symptom Scale (CM-SS) Total Score at Week 12 and 24
timeFrame: Baseline,12th week±3 days, 24th week±3 days
measure: The Change From Baseline in The Serum Level of Acetylcholine and Acetylcholinesterase at Week 24
timeFrame: Baseline, 24th week±3 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Li Hao
state: Beijing
Study officials:
affiliation: Institute of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences,
name: Hao Li
role: STUDY_CHAIR
References:
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.