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

Primary Purpose

Mild Cognitive Impairment, Biomarker, Diagnosis

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Huperzine A
Placebo
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

treatment group

Placebo group

Arm Description

Huperzine A treatment.

The placebo in 52 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 8, 2016
Last Updated
April 13, 2019
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT02931136
Brief Title
Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging
Official Title
Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
Detailed Description
This is a randmized, double-blind, placebo-controll study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Biomarker, Diagnosis, Treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Active Comparator
Arm Description
Huperzine A treatment.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The placebo in 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Huperzine A
Other Intervention Name(s)
shuang yi ping
Intervention Description
The participants will treatment by the Huperzine A 200 ug/day in 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The participants will treatment by the placebo in 52 weeks.
Primary Outcome Measure Information:
Title
The average annual conversion rate in patients of MCI due to AD convert to the AD.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Wang, M.D., Ph.D.
Phone
00862164387250
Ext
73440
Email
wtshhwy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shifu Xiao, M.D., Ph.D.
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Yang, M.D.
Phone
00862164387250
Email
yang08631@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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