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

Shanghai Mental Health Center

Status and phase: Not yet enrolling; Phase 4

Conditions: Treatment; Mild Cognitive Impairment; Diagnosis; Biomarker

Treatments: Drug: Placebo; Drug: Huperzine A

Study type: Interventional

Funder types: Other

Identifiers

NCT02931136

Shanghai Mental Health Center

Details and patient eligibility

About

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.

Full description

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

Enrollment: 300 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

treatment group

Active Comparator group

Description:

Huperzine A treatment.

Treatment:

Drug: Huperzine A

Placebo group

Placebo Comparator group

Description:

The placebo in 52 weeks.

Treatment:

Drug: Placebo