DAOIB for the Treatment of Mild Cognitive Impairment

Chang Gung Medical Foundation

Status and phase: Completed; Phase 2

Conditions: Mild Cognitive Impairment

Treatments: Drug: DAOIB; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04736355

201800387A3

Details and patient eligibility

About

NMDA neurotransmission plays an important role in learning and memory. NMDA receptor-enhancing agent improved the cognitive function of patients with early-phase Alzheimer's disease. This study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be allocated randomly to 2 groups: (1) DAOIB group; (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: 88 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 psychiatric disorders
• 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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88 participants in 2 patient groups, including a placebo group

DAOIB

Experimental group

Description:

oral, for 24 weeks

Treatment:

Drug: DAOIB

Placebo

Placebo Comparator group

Description:

oral, for 24 weeks

Treatment:

Drug: Placebo