DAOIB for the Treatment of Mild Cognitive Impairment

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04736355
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Drug: DAOIB; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: DAOIB for the Treatment of Mild Cognitive Impairment
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DAOIB oral, for 24 weeks	Drug: DAOIB; oral, for 24 weeks
Placebo Comparator: Placebo oral, for 24 weeks	Drug: Placebo; oral, for 24 weeks

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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).

3. 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.

4. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital	Kaohsiung		Taiwan	886

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04736355
• Other Study ID Numbers: 201800387A3
• First Posted: Feb 3, 2021
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

No Results Posted as of Mar 10, 2022