NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment

Chang Gung Medical Foundation

Status and phase: Completed; Phase 2

Conditions: Mild Cognitive Impairment

Treatments: Drug: Placebo; Drug: DAOIB

Study type: Interventional

Funder types: Other

Identifiers

NCT02239003

103-3642C

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of mild cognitive impairment
• MMSE between 17-26
• CDR 0.5

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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24 participants in 2 patient groups, including a placebo group

DAOIB

Experimental group

Description:

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

Treatment:

Drug: DAOIB

Placebo

Placebo Comparator group

Description:

placebo, oral, for 24 weeks

Treatment:

Drug: Placebo