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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Treatments: Other: Placebo; Drug: DAOI-B

Study type: Interventional

Funder types: Other

Identifiers

NCT01600469

99-2452A3

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups, including a placebo group

DAOI-B

Experimental group

Treatment:

Drug: DAOI-B

Placebo

Placebo Comparator group

Treatment:

Other: Placebo