Health TrialsbyHealthPanel

NMDA Enhancement Combined With Omega-3 for Early Dementia

ConditionsOmega 3 Fatty AcidsDementia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-100
SponsorChang Gung Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of Alzheimer's disease or mild cognitive impairment

MMSE between 10-26

CDR 1 or 0.5

Disqualifiers

Hachinski Ischemic Score > 4

Substance abuse/dependence

Parkinson disease, epilepsy, dementia with psychotic features

Major depressive disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • DAOIB+Omega-3

    Drug

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

  • DAOIB+Placebo

    Drug

    Placebo

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: DAOIB+Omega-3Experimental treatment 1 intervention
Group B: DAOIB+PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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

Time frame
week 8, 16, 24
2

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

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

Time frame
week 0, 8, 16, 24
3

Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) 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

Time frame
week 0, 8, 16, 24
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chang Gung Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: