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

NCT ID: NCT02931136

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2025-12-31

Brief Summary

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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

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

Conditions

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Mild Cognitive Impairment Biomarker Diagnosis Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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treatment group

Huperzine A treatment.

Group Type ACTIVE_COMPARATOR

Huperzine A

Intervention Type DRUG

The participants will treatment by the Huperzine A 200 ug/day in 52 weeks.

Placebo group

The placebo in 52 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The participants will treatment by the placebo in 52 weeks.

Interventions

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Huperzine A

The participants will treatment by the Huperzine A 200 ug/day in 52 weeks.

Intervention Type DRUG

Placebo

The participants will treatment by the placebo in 52 weeks.

Intervention Type DRUG

Other Intervention Names

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shuang yi ping

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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xiaoshifu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shifu Xiao, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

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Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Tao Wang, M.D., Ph.D.

Role: CONTACT

00862164387250 ext. 73440

Facility Contacts

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Weimin Yang, M.D.

Role: primary

00862164387250

Other Identifiers

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Shanghai Mental Health Center

Identifier Type: -

Identifier Source: org_study_id

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