Guilingji Capsule for Mild-to-moderate Cognitive Impairment

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Cognitive Dysfunction

Treatments: Drug: Gulingji capsules; Drug: Ginko Biloba Extract tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03647384

2018XLA039-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 348 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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348 participants in 2 patient groups

Intervention

Experimental group

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.

Treatment:

Drug: Gulingji capsules

Control

Active Comparator group

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.

Treatment:

Drug: Ginko Biloba Extract tablet