Back to results

NMDA Enhancement Combined With Omega-3 for Early Dementia

Primary Purpose

Omega 3 Fatty Acids, Dementia

Status

Not yet recruiting

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

DAOIB+Omega-3

DAOIB+Placebo

About this trial

This is an interventional treatment trial for Omega 3 Fatty Acids

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DAOIB+Omega-3

DAOIB+Placebo

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

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

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

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

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).

Full Information

NCT ID

NCT05181189

First Posted

December 23, 2021

Last Updated

February 8, 2023

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05181189

Brief Title

NMDA Enhancement Combined With Omega-3 for Early Dementia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

July 31, 2026 (Anticipated)

Study Completion Date

July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Omega 3 Fatty Acids, Dementia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DAOIB+Omega-3

Arm Type

Experimental

Arm Title

DAOIB+Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

DAOIB+Omega-3

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

DAOIB+Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24

Description

Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)

Time Frame

week 0, 8, 16, 24

Secondary Outcome Measure Information:

Title

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

Description

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

Title

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

Description

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

Time Frame

week 0, 8, 16, 24

Title

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

Description

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

Title

Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24

Description

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

Title

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

Description

Time Frame

week 0, 8, 16, 24

Title

Change from baseline in the composite score of a battery of additional cognitive tests at week 24

Description

Time Frame

week 0, 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Kaohsiung Chang Gung Memorial Hospital

City

Kaohsiung

ZIP/Postal Code

886

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

NMDA Enhancement Combined With Omega-3 for Early Dementia

We'll reach out to this number within 24 hrs