Novel Augmentation of DAOIB and Antioxidant for Early Dementia

NCT ID: NCT06467539

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-19

Study Completion Date

2027-05-31

Brief Summary

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Previous studies found that some NMDA-enhancing agents were able to improve cognitive function of patients with early-phase dementia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of dementia too. Whether combined treatment of an NMDA-enhancing agent and a drug with antioxidant property can be better than an NMDA-enhancing agent alone deserves study.

Detailed Description

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Conditions

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Alzheimer Disease Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental

DAOIB plus Antioxidant agent (AO)

Group Type EXPERIMENTAL

DAOIB plus AO

Intervention Type DRUG

oral, for 24 weeks

Placebo Comparator

DAOIB plus Placebo

Group Type PLACEBO_COMPARATOR

DAOIB plus placebo

Intervention Type DRUG

oral, for 24 weeks

Interventions

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DAOIB plus AO

oral, for 24 weeks

Intervention Type DRUG

DAOIB plus placebo

oral, for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Chieh-Hsin Lin, MD, PhD

Role: primary

886-7-7317123 ext. 8753

Other Identifiers

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202200458A3C502

Identifier Type: -

Identifier Source: org_study_id

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