DAOIB for the Treatment of Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

DAOIB for the Treatment of Mild Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04736355
• Other study ID #: 201800387A3
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• DAOIB
oral, for 24 weeks
• Placebo
oral, for 24 weeks

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24	Alzheimer's disease assessment scale-cognitive subscale consists of 11 tasks. Its scores range from 0 (best) to 70 (worst).	week 0, 8, 16, 24
Secondary	Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 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.	week 8, 16, 24
Secondary	Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 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).	week 0, 8, 16, 24
Secondary	Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24	The SF-36 consists of eight sections which assess the quality of life.	week 0, 8, 16, 24
Secondary	Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 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)	week 0, 24