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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02931136
• Other study ID #: Shanghai Mental Health Center
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 2019
• Est. completion date: December 2025

Study information

• Verified date: April 2019
• Source: Shanghai Mental Health Center
• Contact: Tao Wang, M.D., Ph.D.
• Phone: 00862164387250
• Email: wtshhwy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Biomarker
• Cognitive Dysfunction
• Diagnosis
• Mild Cognitive Impairment
• Plaque, Amyloid
• Treatment

Intervention

Drug:
• Huperzine A
The participants will treatment by the Huperzine A 200 ug/day in 52 weeks.
• Placebo
The participants will treatment by the placebo in 52 weeks.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average annual conversion rate in patients of MCI due to AD convert to the AD.		52 weeks