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DAOIB for the Treatment of Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
DAOIB
Placebo
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DAOIB

Placebo

Arm Description

oral, for 24 weeks

oral, for 24 weeks

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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.
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)

Full Information

First Posted
January 31, 2021
Last Updated
August 29, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04736355
Brief Title
DAOIB for the Treatment of Mild Cognitive Impairment
Official Title
DAOIB for the Treatment of Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
886
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chieh-Hsin Lin, MD, PhD
Phone
886-7-7317123
Ext
8753
Email
cyndi36@gmail.com
First Name & Middle Initial & Last Name & Degree
Chieh-Hsin Lin, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

DAOIB for the Treatment of Mild Cognitive Impairment

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