Efficacy Biomarkers of DAOIB for Dementia

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05582161

Collaborator

(none)

123

Enrollment

Location

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This open-label clinical trial will enroll patients with aMCI or mild AD, and they will be treated with DAOIB for 24 weeks. We will assess the patients before entering the study, 8 weeks, 16 weeks, and end point (24 weeks) of the study, and measure blood NMDA and oxidative stress - related biomarkers every 8 weeks. We hypothesize that NMDA and oxidative stress - related biomarkers can predict the efficacy of DAOIB for patients with aMCI or mild AD.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Drug: DAOIB	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

123 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy Biomarkers of DAOIB for Dementia

Actual Study Start Date :

Oct 3, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Outcome Measures

Primary Outcome Measures

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 scores range from 0 (best) to 70 (worst)

Secondary Outcome Measures

Change from baseline in the composite score of a battery of additional cognitive tests at week 24 [week 0, 24]
The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (Wechsler Memory Scale, Spatial Span), verbal/nonverbal learning and memory tests (Wechsler Memory Scale, Word Listing)
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]
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
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]
The assessment appears to be a suitable instrument for evaluating activities of daily living in early-phase dementia. Its scores range from 0 (worst) to 78 (best)
Change from baseline of Geriatric Depression Scale [week 0, 8, 16, 24]
Assessment of geriatric depressive symptoms
Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24 [week 0, 8, 16, 24]
Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
MMSE between 10-26
CDR 1 or 0.5

Exclusion Criteria:

Hachinski Ischemic Score > 4
Substance abuse/dependence
Parkinson disease, epilepsy, dementia with psychotic features
Major depressive disorder
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:

NCT05582161

Other Study ID Numbers:

202101070A3

First Posted:

Oct 17, 2022

Last Update Posted:

Oct 17, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dementia

Study Results

No Results Posted as of Oct 17, 2022