Novel Augmentation of DAOIB and Antioxidant for Early Dementia

Chang Gung Medical Foundation

Status and phase: Enrolling; Phase 2

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Treatments: Drug: DAOIB plus AO; Drug: DAOIB plus placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06467539

202200458A3C502

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

DAOIB plus Antioxidant agent (AO)

Treatment:

Drug: DAOIB plus AO

Placebo Comparator

Placebo Comparator group

Description:

DAOIB plus Placebo

Treatment:

Drug: DAOIB plus placebo