Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging
1 other identifier
interventional
300
1 country
1
Brief Summary
The purpose of this study is based on the Flutemetamol-PET senile plaque imaging to investigate the peripheral blood biochemical and brain MRI imaging biomarkers and to research completely independent intellectual property rights neuropsychological test tool for the MCI due to AD. At the same time, the investigators will study the efficacy and safety of early treatment of MCI due to AD by Huperzine A in 52 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2019
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2016
CompletedFirst Posted
Study publicly available on registry
October 12, 2016
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 16, 2019
April 1, 2019
5.1 years
October 8, 2016
April 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The average annual conversion rate in patients of MCI due to AD convert to the AD.
52 weeks
Study Arms (2)
treatment group
ACTIVE COMPARATORHuperzine A treatment.
Placebo group
PLACEBO COMPARATORThe placebo in 52 weeks.
Interventions
The participants will treatment by the Huperzine A 200 ug/day in 52 weeks.
Eligibility Criteria
You may qualify if:
- memory complaint, preferably corroborated by a spouse or relative.
- objective memory impairment.
- normal general cognitive function.
- intact activities of daily living.
- absence of dementia.
- the positive of brain senile plaque.
You may not qualify if:
- more than two lacuna ischemia (of diameter \< 1 cm) as revealed by MRI fluid-attenuated inversion recovery (FLAIR) sequence.
- other type of dementia except AD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shifu Xiao, M.D., Ph.D.
Shanghai Mental Health Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
October 8, 2016
First Posted
October 12, 2016
Study Start
November 1, 2019
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
April 16, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share