Trial intelligence / Profile preview

DAOIB + Omega-3 in Early Dementia

NCT05181189Phase 2

Key facts

Status: Not yet recruiting
Start: Jan 2027
Primary completion: Dec 2029
Countries: 1
Sponsor: Chang Gung Memorial Hospital
Modality: Small Molecules

Drugs: omega-3 fatty acid
Conditions: Alzheimer's disease (AD)Mild Cognitive Impairment (MCI)

Overview

Phase 2, randomised, double-blind trial of omega-3 fatty acid in Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI) (2 arms), sponsored by Chang Gung Memorial Hospital. Primary endpoint: Alzheimer's Disease Assessment Scale - Cognitive Subscale at 24 weeks. Planned start Jan 2027; status: not yet recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

DAOIB+Omega-3
DAOIB combined with Omega-3 fatty acids
DAOIB+Placebo
DAOIB combined with Placebo

Who it enrols

Patients with a clinical diagnosis of Alzheimer's disease or mild cognitive impairment, MMSE between 10-26, and CDR 1 or 0.5. Excludes patients with Hachinski Ischemic Score > 4, substance abuse, Parkinson disease, epilepsy, dementia with psychotic features, major depressive disorder, major physical illnesses, recent memantine or omega-3 therapy, and severe visual or hearing impairment.

Endpoints

Primary

Alzheimer's Disease Assessment Scale - Cognitive Subscale24 weeks

Secondary

Clinician's Interview-Based Impression of Change plus Caregiver Input24 weeks
Mini-Mental State Examination24 weeks
Clinical Dementia Rating Scale Sum of Boxes24 weeks
Alzheimer's Disease Cooperative Study scale for ADL in MCI24 weeks
Quality of Life24 weeks
Composite score of a battery of additional cognitive tests24 weeks

Beyond the preview

Go deeper on NCT05181189.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT05181189.