Guilingji Capsule for Mild-to-moderate Cognitive Impairment

NCT03647384 | Unknown Phase 2

• 1 other identifier: 2018XLA039-2
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction

Keywords

Traditional Chinese medicine; Randomized clinical trial; Mild-to-moderate cognitive impairment

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline,12th week±3 days, 24th week±3 days

• 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.

  Baseline,12th week±3 days, 24th week±3 days

Secondary Outcomes (5)

• The Change From Baseline in Clinical Dementia Rating (CDR) Total Score at Week 12 and 24

  Baseline,12th week±3 days, 24th week±3 days

• The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score at Week 12 and 24

  Baseline,12th week±3 days, 24th week±3 days

• The Change From Baseline in Activities of Daily Living (ADL) Total Score at Week 12 and 24

  Baseline,12th week±3 days, 24th week±3 days

• The Change From Baseline in The Chinese Medicine Symptom Scale (CM-SS) Total Score at Week 12 and 24

  Baseline,12th week±3 days, 24th week±3 days

• The Change From Baseline in The Serum Level of Acetylcholine and Acetylcholinesterase at Week 24

  Baseline, 24th week±3 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Gulingji capsules DRUG

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

Ginko Biloba Extract tablet DRUG

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.

Control

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead
• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: collaborator
• Beijing Xuanwu Traditional Chinese Medicine Hospital: collaborator
• Beijing Hospital: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• Peking University First Hospital: collaborator
• Huadong Hospital: collaborator
• Longhua Hospital: collaborator
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator
• The Affiliated Hospital of Shandong University of TCM: collaborator
• Shanxi Dayi Hospital: collaborator
• Shaanxi Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Li Hao

Beijing, Beijing Municipality, 100091, China

Location

Related Publications (1)

• 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.

  PMID: 32761337 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hao Li

  Institute of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences,

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: August 22, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

CN (1)