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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002171-11 | EudraCT Number |
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The goal of this clinical trial is to assess the degree of improvement in cognitive functions, including memory, attention, thinking, executive and language functions in diagnosed patients MCI and AD taking dimethyl fumarate 480 mg daily compared to patients taking placebo. Participant will be 55 to 90 years old, both genders. The main question it aims to answer is: Changing the degree of cognitive improvement based on the RBANS score among patients diagnosed with MCI and AD after completing dimethyl fumarate therapy test group compared to the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assessment of the degree of improvement in cognitive functions in diagnosed patients MCI and AD. | Placebo Comparator | Assessment of the degree of improvement in cognitive functions, including memory, attention, thinking, executive and language functions in diagnosed patients MCI and AD taking dimethyl fumarate 480 mg daily compared to patients taking placebo. |
|
| Assessment of the safety of therapy | Other | Assessment of the safety of therapy |
|
| Assessment of the impact of therapy on patients' daily functioning | Placebo Comparator | Assessment of the impact of therapy on patients' daily functioning - Scale Alzheimer's Disease Cooperative Study - Activity of Daily Living (ADCS-ADL). |
|
| Assessment of the impact of therapy on the presence of symptoms neuropsychiatric/behavioral disorder | Placebo Comparator | Assessment of the impact of therapy on the presence of symptoms neuropsychiatric/behavioral disorders in patients scale Neuropsychiatric Inventory (NPI), Geriatric Depression Scale (GDS). |
|
| Assessment of the impact of therapy on the quality of life of patients and their caregivers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug | 480 mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the degree of cognitive improvement based on the RBANS score among patients diagnosed with MCI and AD after completing dimethyl fumarate therapy test group compared to the placebo group. | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a neuropsychological measure used in the assessment of cognitive function in older adults, studies of mild cognitive impairment and Alzheimer's disease dementia, and studies evaluating the effectiveness of therapeutic interventions. The test generates index scores in five neurocognitive domains, as well as a Total Scale Index score. The RBANS is characterized by high sensitivity in detecting disease and assessing changes in scores during treatment in patients with MCI in the course of Alzheimer's disease. with MCI and AD after completing dimethyl fumarate therapy test group compared to the placebo group. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety of therapy | 15 months | |
| Assessment of the impact of therapy on the daily functioning of patients - Alzheimer's Disease Cooperative Study - Activity of Daily Living (ADCS-ADL) scale. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the effect of therapy on peripheral markers of oxidative stress and pro-inflammatory markers. | 6 months | |
| Assessment of the degree of reduction of the MCI progression rate to dementia after the end of the clinical phase of the study. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical University of Lodz Medical University of Lodz | Contact | +48 422725239 | cwbk@umed.lodz.pl | |
| Jakub Kazmierski, PhD | Contact | +48 426757372 | jakub.kazmierski@umed.lodz.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz | Recruiting | Lodz | Łódź Voivodeship | 92-213 | Poland |
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Assessment of the impact of therapy on the quality of life of patients and their caregivers (scales EQ-5D; Zarit Burden Interview). |
| reducing the degree of brain atrophy in patients - MRI examination | Placebo Comparator | Assessment of the impact of therapy on reducing the degree of brain atrophy in patients from the active group compared to the control group (MRI examination) |
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| impact of therapy on improvement in functional connections assessed in rs-fMRI rs-EEG | Placebo Comparator | Assessment of the impact of therapy on improvement in functional connections assessed in rs-fMRI and rs-EEG |
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| Effect of therapy on peripheral markers of oxidative stress and pro-inflammatory markers | Placebo Comparator | Assessment of the effect of therapy on peripheral markers of oxidative stress and pro-inflammatory markers |
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| degree of reduction in the rate of progression from MCI to dementia after completion | Placebo Comparator | Assesment of the degree of reduction in the rate of progression from MCI to dementia after completion of the clinical phase of the study |
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| degree of improvement in cognitive functions using the MMSE and CDR scales | Placebo Comparator | Assessment of the degree of improvement in cognitive functions using the MMSE and CDR scales |
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| Assessment of the impact of therapy on the presence of neuropsychiatric symptoms/behavioral disorders in patients using the Neuropsychiatric Inventory (NPI) scale and the Geriatric Depression Scale (GDS). | 15 months |
| Assessment of the impact of therapy on the quality of life of patients and their caregivers (EQ-5D scales; Zarit Burden Interview). | 12 months |
| Assessment of the effect of therapy on the reduction of the degree of brain atrophy in patients from the active group compared to the control group (MRI study). | 6 months |
| Assessment of the effect of therapy on the improvement of functional connections assessed in rs-fMRI and rs-EEG. | EEG and MRI data will be processed using standard processing pipelines. The results will be a topographic map of the EEG frequency band distribution on the brain surface, temporal and time-frequency analyses based on FFT and wavelets, entropy analysis, and EEG coherence markers. Then, inverse localization of EEG signals generated on the scalp over the brain surface will be performed. Particular emphasis will be put on frontal structures and areas detected by MRI clustering. We will perform machine learning-based clustering of EEG and MRI data to detect significant features. CDR "Clinical Dementia Rating Assessment" score from 0.5 to 2 | 15 months |
| Assessment of the degree of improvement of cognitive functions using the MMSE and CDR scales. | MMSE (Mini-Mental State Examination) score from 17 to 30 points CDR (The Clinical Dementia Rating) score from 0,5 to 2 points | 15 months |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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