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Clinical Trials/NCT02931136
NCT02931136
Not yet recruiting
Phase 4

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

Shanghai Mental Health Center1 site in 1 country300 target enrollmentNovember 2019

Overview

Phase
Phase 4
Intervention
Placebo
Conditions
Mild Cognitive Impairment
Sponsor
Shanghai Mental Health Center
Enrollment
300
Locations
1
Primary Endpoint
The average annual conversion rate in patients of MCI due to AD convert to the AD.
Status
Not yet recruiting
Last Updated
7 years ago

Overview

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
November 2019
End Date
December 2025
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

xiaoshifu

Director

Shanghai Mental Health Center

Eligibility Criteria

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

Arms & Interventions

Placebo group

The placebo in 52 weeks.

Intervention: Placebo

treatment group

Huperzine A treatment.

Intervention: Huperzine A

Outcomes

Primary Outcomes

The average annual conversion rate in patients of MCI due to AD convert to the AD.

Time Frame: 52 weeks

Study Sites (1)

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