NMDA Enhancement Combined With Omega-3 for Early Dementia

Phase 2Not Yet RecruitingNCT05181189

Chang Gung Memorial Hospital140 enrolled

Overview

In this 4-year proposed project, we will enroll 140 patients with aMCI or mild AD into a 24-week randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to one of two treatment groups for 24 weeks (n = 70 in each group) in a double-blind manner: \[1\] DAOIB + omega-3; \[2\] DAOIB + placebo. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB combined with omega-3 will yield better efficacy than placebo in improving the cognitive function, global functioning and quality of life in patients with aMCI or mild AD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

140

Conditions

Omega 3 Fatty Acids Dementia

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 100 Years

Medical Language ↔ Plain English

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 * memantine or special omega-3 fatty acids therapy within 3 months before enrollment * Severe visual or hearing impairment

Outcomes

Primary Outcomes

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

Time frame: week 0, 8, 16, 24

Secondary Outcomes

Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24

Time frame: week 8, 16, 24

Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24

Time frame: week 0, 8, 16, 24

Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) at week 8, 16 and 24

Time frame: week 0, 8, 16, 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

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)

Time frame: week 0, 8, 16, 24

Change from baseline in Quality of life score at week 8, 16 and 24

Quality of life will be assessed by Medical Outcomes Study Short-Form-36 (SF-36). The SF-36 consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health.

Time frame: week 0, 8, 16, 24

Change from baseline in the composite score of a battery of additional cognitive tests at week 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).

Time frame: week 0, 24

NMDA Enhancement Combined With Omega-3 for Early Dementia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes