NMDA Enhancement Combined With Omega-3 for Early Dementia

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05181189

Collaborator

(none)

140

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Omega 3 Fatty Acids Dementia	Drug: DAOIB+Omega-3 Drug: DAOIB+Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

NMDA Enhancement Combined With Omega-3 Fatty Acids for the Treatment of Early Dementia

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 31, 2026

Anticipated Study Completion Date :

Jul 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DAOIB+Omega-3	Drug: DAOIB+Omega-3 The omega-3 fatty acids dose will be adjusted every 8 weeks according to clinical evaluation.
Placebo Comparator: DAOIB+Placebo	Drug: DAOIB+Placebo Placebo

Arm

Intervention/Treatment

Experimental: DAOIB+Omega-3

Drug: DAOIB+Omega-3

The omega-3 fatty acids dose will be adjusted every 8 weeks according to clinical evaluation.

Placebo Comparator: DAOIB+Placebo

Drug: DAOIB+Placebo

Placebo

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 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 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
Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) at week 8, 16 and 24 [week 0, 8, 16, 24]
Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) 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 in Quality of life score at week 8, 16 and 24 [week 0, 8, 16, 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.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 100 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
memantine or special omega-3 fatty acids therapy within 3 months before enrollment
Severe visual or hearing impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung 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:

NCT05181189

Other Study ID Numbers:

111-0510163

First Posted:

Jan 6, 2022

Last Update Posted:

Jan 6, 2022

Last Verified:

Dec 1, 2021

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 Jan 6, 2022