NMDA Enhancer for the Treatment of Mild Alzheimer's Disease

Chang Gung Medical Foundation

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: DAOI-B group; Drug: DAOI-A group; Drug: Placebo oral capsule; Drug: DAOI-C group

Study type: Interventional

Funder types: Other

Identifiers

NCT03752463

105-3412C

Details and patient eligibility

About

NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with AD.

Enrollment: 154 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Alzheimer's disease
• MMSE between 10-26
• CDR 1

Exclusion criteria

• Hachinski Ischemic Score > 4
• Substance abuse/dependence
• Parkinson disease, epilepsy, dementia with psychotic features
• Major depressive disorder
• Major physical illnesses
• Severe visual or hearing impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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154 participants in 4 patient groups, including a placebo group

DAOI-A group

Experimental group

Treatment:

Drug: DAOI-A group

DAOI-B group

Experimental group

Treatment:

Drug: DAOI-B group

DAOI-C group

Experimental group

Treatment:

Drug: DAOI-C group

Placebo group

Placebo Comparator group

Treatment:

Drug: Placebo oral capsule