NCT03647384

Guilingji Capsule for Mild-to-moderate Cognitive Impairment

Efficacy and Safety of Guilingji Capsule in Older Adults With Mild-to-Moderate Cognitive Impairment (Kidney and Marrow Deficiency Pattern)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 348 (estimated)
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cognitive Dysfunction

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-08-22
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-08-27
• Last updated: 2018-08-27

Locations

1 site across 1 country: China