Alzheimer’s disease
Conditions
Brief summary
Change in cognitive performance as assessed by RBANS scores between the post-treatment visit (V9) and the randomisation visit (V1).
Detailed description
Assessment of the daily functioning of patients based on the ADCS-ADL scale, Assessment of the presence of neuropsychiatric symptoms / behavioral disorders in patients using the NPI, GDS scale),, Assessment of the quality of life of patients and their caregivers based on the EQ-5D scales, Zarit Burden Interview,, Assessment of the expression of peripheral markers of oxidative stress and pro-inflammatory markers., Improvement of cognitive functions using MMSE, CDR in patients diagnosed with MCI and AD receiving dimethyl fumarate after the end of therapy compared to the placebo group., Difference in frequency and severity of reported adverse events in the active group versus the placebo group.
Interventions
DRUGDIMETHYL FUMARATE
Sponsors
Medical University Of Lodz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cognitive performance as assessed by RBANS scores between the post-treatment visit (V9) and the randomisation visit (V1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the daily functioning of patients based on the ADCS-ADL scale, Assessment of the presence of neuropsychiatric symptoms / behavioral disorders in patients using the NPI, GDS scale),, Assessment of the quality of life of patients and their caregivers based on the EQ-5D scales, Zarit Burden Interview,, Assessment of the expression of peripheral markers of oxidative stress and pro-inflammatory markers., Improvement of cognitive functions using MMSE, CDR in patients diagnosed with MCI and AD receiving dimethyl fumarate after the end of therapy compared to the placebo group., Difference in frequency and severity of reported adverse events in the active group versus the placebo group. | — |
Countries
Poland
Outcome results
None listed