Early Diagnosis and Early Treatment of Alzheimer's Diseas... | NCT02931136

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

NCT02931136

Sponsor

Shanghai Mental Health Center

Status

Unknown status

Last Update Posted

Apr 16, 2019Actual

Enrollment

300Estimated

Phase

Phase 4

Conditions

Mild Cognitive Impairment
Biomarker
Diagnosis
Treatment

Interventions

Huperzine A
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2019Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Oct 8, 2016

First Submission Date that Met QC Criteria

Oct 11, 2016

First Posted Date

Oct 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2019

Last Update Posted Date

Apr 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment group	Active Comparator	Huperzine A treatment.	Drug: Huperzine A
Placebo group	Placebo Comparator	The placebo in 52 weeks.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Huperzine A	Drug	The participants will treatment by the Huperzine A 200 ug/day in 52 weeks.	treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The average annual conversion rate in patients of MCI due to AD convert to the AD.		52 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tao Wang, M.D., Ph.D.	Contact	00862164387250	73440	wtshhwy@163.com

Overall Officials

Name	Affiliation	Role
Shifu Xiao, M.D., Ph.D.	Shanghai Mental Health Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Mental Health Center		Shanghai	Shanghai Municipality	200030	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction
D004194	Disease

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C050426	huperzine A

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided