Clincosm LogoSign in Get a demo

Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT02931136
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
73
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Huperzine A
  • Drug: Placebo
 Phase 4

Detailed Description

This is a randmized, double-blind, placebo-controll study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging
Anticipated Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: treatment group

Huperzine A treatment.

Drug: Huperzine A
The participants will treatment by the Huperzine A 200 ug/day in 52 weeks.
Other Names:
  • shuang yi ping

    		•
    Placebo Comparator: Placebo group

    The placebo in 52 weeks.

    Drug: Placebo
    The participants will treatment by the placebo in 52 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. The average annual conversion rate in patients of MCI due to AD convert to the AD. [52 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Mental Health Center Shanghai Shanghai China 200030

    Sponsors and Collaborators

    • Shanghai Mental Health Center

    Investigators

    • Principal Investigator: Shifu Xiao, M.D., Ph.D., Shanghai Mental Health Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    xiaoshifu, Director, Shanghai Mental Health Center
    ClinicalTrials.gov Identifier:
    NCT02931136
    Other Study ID Numbers:
    • Shanghai Mental Health Center
    First Posted:
    Oct 12, 2016
    Last Update Posted:
    Apr 16, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alzheimer Disease
    Disease
    Plaque, Amyloid
    Cognitive Dysfunction
    Huperzine A

    Study Results

    No Results Posted as of Apr 16, 2019