DAOIB for the Treatment of Mild Cognitive Impairment

Phase 2

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Drug: DAOIB; Drug: Placebo

• Registration Number: NCT04736355
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-01-31
• Study First Submitted QC: 2021-01-31
• Study First Posted: 2021-02-03
• Status Verified: 2024-02
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAOIB	DAOIB	oral, for 24 weeks
Placebo	Placebo	oral, for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24	week 0, 8, 16, 24	Alzheimer's disease assessment scale-cognitive subscale consists of 11 tasks. Its scores range from 0 (best) to 70 (worst).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24	week 8, 16, 24	Clinician's Interview-Based Impression of Change plus Caregiver Input score is a global assessment of change based on a comprehensive, semi-structured interview which includes caregiver-supplied information. It is a 7-point rating scale ranging from 1-7, where 1 represents markedly improved; 4, no change; and 7, markedly worse.
Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24	week 0, 8, 16, 24	ADCS-MCI-ADL appears to be a suitable instrument for evaluating activities of daily living in mild cognitive impairment. Its scores range from 0 (worst) to 78 (best).
Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24	week 0, 8, 16, 24	The SF-36 consists of eight sections which assess the quality of life.
Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24	week 0, 24	The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (verbal and nonverbal, Wechsler Memory Scale), learning and memory tests (verbal and visual, Wechsler Memory Scale)

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan