NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-05-31

Brief Summary

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NMDA activation plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive function impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment or mild Alzheimer's disease.

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Detailed Description

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Conditions

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Alzheimer's Disease Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DAOI-B

Group Type EXPERIMENTAL

DAOI-B

Intervention Type DRUG

250-1500 mg/day, oral, for 24 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo, oral, for 24 weeks

Interventions

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DAOI-B

250-1500 mg/day, oral, for 24 weeks

Intervention Type DRUG

Placebo

placebo, oral, for 24 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of mild cognitive impairment or mild Alzheimer's
* MMSE between 17-26
* CDR 0.5 or 1

Exclusion Criteria

* Hachinski Ischemic Score \> 4
* substance abuse/dependence
* Parkinson disease
* epilepsy
* major depressive disorder
* dementia with psychotic features
* major physical illnesses
* severe visual or hearing impairment

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No