NMDA Enhancement Combined With Omega-3 for Early Dementia

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05181189
• Other study ID #: 111-0510163
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: June 2027

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Drug:
• DAOIB+Omega-3
The omega-3 fatty acids dose will be adjusted every 8 weeks according to clinical evaluation.
• DAOIB+Placebo
Placebo

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	week 0, 8, 16, 24
Secondary	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	week 8, 16, 24
Secondary	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	week 0, 8, 16, 24
Secondary	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	week 0, 8, 16, 24
Secondary	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)	week 0, 8, 16, 24
Secondary	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.	week 0, 8, 16, 24
Secondary	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).	week 0, 24