Study of Huperzine A Sustained-Release Tablets in Patients With Alzheimer's Disease
A Multi-Center, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Study to Evaluate the Safety and Efficacy of Huperzine A Sustained-Release Tablets in Patients With Mild to Moderate Alzheimer's Disease
1 other identifier
interventional
390
1 country
1
Brief Summary
The main purpose of this study is to evaluate the safety and efficacy of Huperzine A sustained release tablets in patients with mild to moderate Alzheimer's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 24, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJanuary 25, 2011
January 1, 2011
2.1 years
January 24, 2011
January 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Alzheimer's Disease Assessment Scale - Cognitive Subscale
week 24
Secondary Outcomes (3)
Clinician's Interview Based Impression of Change, plus caregiver input
week 24
Activities of Daily Living
week 24
Neuropsychiatric Inventory
week 24
Study Arms (3)
Huperzine A Sustained-Release Tablet
EXPERIMENTALHuperzine A Tablet
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Sustained-Release Tablet, 400µg once a day, 24 weeks
Eligibility Criteria
You may qualify if:
- Male/female patient aged between 50 and 85
- Clinical diagnosis of mild to moderate probable AD based on DSM-IV and the NINCDS-ADRDA criteria
- Middle school or above: 11 ≤MMSE ≤ 24, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16;
- CT or MRI scan excluding another structural brain disease;
- Hachinski Ischemic Score \< 4
- Hamilton Depression Scale ≤10
- Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study.
You may not qualify if:
- Proven or clinically suspected other type of dementia such as vascular dementia, mechanic or chemical caused dementia, vitamin B12 deficiency, hypothyroidism etc.
- Epileptic Patient
- Severe liver or renal disease
- Resting pulse less than 50
- Mechanical intestinal obstruction patient
- History of stroke
- History of angina or other severe cardiac, vascular, lung, gastrointestinal and hematopoietic system disease
- Cognitive damage caused by alcohol or substance abuse
- Disable to participate or cooperate in the protocol
- Use of any agent for the treatment of dementia within 2 weeks of randomization
- Use of another investigational agent within 3 months of screening
- Be sensitive to Huperzine A or other ACHEIs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 24, 2011
First Posted
January 25, 2011
Study Start
May 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
January 25, 2011
Record last verified: 2011-01