MCIPhase 2NCT06850597
Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease
A Phase 2 study testing dimethyl fumarate in people with MCI and MCI-AD, Early Stage Alzheimer's Disease, run by Medical University of Lodz at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- MCI, MCI-AD, Early Stage Alzheimer's Disease, Alzheimer's Disease
- What is being tested?
- dimethyl fumarate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 28 Oct 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 55-90 years.
- Patients diagnosed with mild cognitive impairment in Alzheimer's disease and mild to moderate Alzheimer's dementia (MMSE >16) diagnosed based on NIA-AA criteria.
- MMSE score from 17 to 30 points.
- CDR score from 0.5 to 2.
- The patient signs an informed, voluntary consent to participate in the study.
- The patient has a close person/de facto guardian who agrees to help the patient during participation in the study.
- At least 6 years of education.
- In the case of anti-Alzheimer's drugs, the use of cholinesterase inhibitors is permitted provided that they are included at least 3 months before entering the study and used at a stable dose for at least 60 days before entering the study. In the case of memantine, its use is permitted provided that it is included at least 4 months before entering the study and used at a stable dose for at least 3 months before entering the study.
Who cannot join
- Lack of informed voluntary consent to participate in the study.
- Patients who cannot read or write.
- Pregnant, breastfeeding or childbearing women who do not use effective contraception (hormonal contraception, surgical sterilization, intrauterine device, condom in combination with vaginal spermicide).
- Participation in another clinical trial, currently or within 3 months prior to the screening visit.
- Liver failure (i.e. cirrhosis or active liver disease), diagnosed acute or chronic hepatitis regardless of cause.
- Chronic kidney disease with GFR below < 60 ml/min/m2
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- Abnormal liver parameters: ALAT exceeding > 2 times the upper limit of normal
- Leukopenia (<4000/mm3), granulocytopenia (<1500/mm3) or lymphopenia (<1000/mm3) regardless of the cause.
- Severe agitation.
- Mental retardation.
- Delirium diagnosed according to DSM-5 criteria.
- Diagnosis of neurological and neurodegenerative diseases other than Alzheimer's disease (multiple sclerosis, Parkinson's disease, Huntington's disease, previous stroke).
- Presence of hemorrhagic foci in magnetic resonance imaging with a diameter of ≥ 2 cm3, more than three (3) ischemic stroke foci with a diameter of ≥ 1.5 cm3 or a single ischemic foci with a diameter of ≥ 2 cm3, presence of vascular malformations, aneurysms, subdural hematoma, normal pressure hydrocephalus, final decision at the discretion of the investigator.
- Severe or uncontrolled somatic disease that could affect the course of the study (e.g. neoplastic, cardiovascular, respiratory, metabolic or digestive, severe renal failure, unstable type I or II diabetes, untreated or uncontrolled clinically significant hypertension).
- Use of benzodiazepines or barbiturates within 1 week prior to screening.
- Pharmacological immunosuppression.
- Patients with bipolar disorder or psychotic disorders or any other psychiatric condition (current or past) that the Investigator believes interferes with the study.
- Alcoholism or drug addiction as defined by DSM-5 within the past 5 years (dependent for more than 1 year and or in remission for less than 3 years).
- Patients with any medical condition that, in the Investigator's judgment, is an exclusion criterion.
- Thyroid hormone therapy initiated, discontinued, or modified within 3 months prior to screening visit.
- Menopausal hormone replacement therapy initiated, discontinued, or modified within 3 months prior to screening visit.
- Use of prohibited drugs in the study: Antineoplastic drugs (no studies). Immunosuppressive drugs (no studies). Corticosteroids (impact on project results). Live attenuated vaccines (no studies). Inactivated vaccines may be used. Benzodiazepines (impact on assessed endpoints). Other ethyl esters used orally or topically.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
Lodz, Łódź Voivodeship, 92-213
Jakub Kaźmierski
About this study
Official title: Randomized, Double-blind, Placebo- Controlled Trial Evaluating Efficacy and Safety of Dimethyl Fumarate in Brain Atrophy Reduction, Synaptic Functional Connectivity, Cognitive Functions, Quality of Life, and Activity of Daily Living Improvement Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease
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.
- Being tested
- dimethyl fumarate
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dimethyl fumarateDrug
480 mg per day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: dimethyl fumarate |
| Assessment of the safety of therapy | Other | Assessment of the safety of therapy Receives: Drug: dimethyl fumarate |
| 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). Receives: Drug: dimethyl fumarate |
| 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). Receives: Drug: dimethyl fumarate |
| Assessment of the impact of therapy on the quality of life of patients and their caregivers | Placebo comparator | 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) Receives: Drug: dimethyl fumarate |
| 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 Receives: Drug: dimethyl fumarate |
| 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 Receives: Drug: dimethyl fumarate |
| 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 Receives: Drug: dimethyl fumarate |
| 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 Receives: Drug: dimethyl fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (6)
Assessment of the safety of therapy
Measured: 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.
Measured: 15 months
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).
Measured: 15 months
Assessment of the impact of therapy on the quality of life of patients and their caregivers (EQ-5D scales; Zarit Burden Interview).
Measured: 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).
Measured: 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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start28 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Kazmierski, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850597
- Sponsor's protocol ID
- 010622
- Other IDs
- 2022-002171-11
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo- Controlled Trial Evaluating Efficacy and Safety of Dimethyl Fumarate in Brain Atrophy Reduction, Synaptic Functional Connectivity, Cognitive Functions, Quality of Life, and Activity of Daily Living Improvement Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06850597
- Acronym / sponsor ID
- 010622
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Assessment of the degree of improvement in cognitive functions in diagnosed patients MCI and AD. | Placebo comparator | Drug: dimethyl fumarateAssessment 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 | Drug: dimethyl fumarateAssessment of the safety of therapy |
| Assessment of the impact of therapy on patients' daily functioning | Placebo comparator | Drug: dimethyl fumarateAssessment 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 | Drug: dimethyl fumarateAssessment 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 | Placebo comparator | –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 | Drug: dimethyl fumarateAssessment 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) |
| impact of therapy on improvement in functional connections assessed in rs-fMRI rs-EEG | Placebo comparator | Drug: dimethyl fumarateAssessment of the impact of therapy on improvement in functional connections assessed in rs-fMRI and rs-EEG |
| Effect of therapy on peripheral markers of oxidative stress and pro-inflammatory markers | Placebo comparator | Drug: dimethyl fumarateAssessment of the effect of therapy on peripheral markers of oxidative stress and pro-inflammatory markers |
| degree of reduction in the rate of progression from MCI to dementia after completion | Placebo comparator | Drug: dimethyl fumarateAssesment of the degree of reduction in the rate of progression from MCI to dementia after completion of the clinical phase of the study |
| degree of improvement in cognitive functions using the MMSE and CDR scales | Placebo comparator | Drug: dimethyl fumarateAssessment of the degree of improvement in cognitive functions using the MMSE and CDR scales |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged 55-90 years.
- Patients diagnosed with mild cognitive impairment in Alzheimer's disease and mild to moderate Alzheimer's dementia (MMSE >16) diagnosed based on NIA-AA criteria.
- MMSE score from 17 to 30 points.
- CDR score from 0.5 to 2.
- The patient signs an informed, voluntary consent to participate in the study.
Key exclusion criteria (22 listed)
- Lack of informed voluntary consent to participate in the study.
- Patients who cannot read or write.
- Pregnant, breastfeeding or childbearing women who do not use effective contraception (hormonal contraception, surgical sterilization, intrauterine device, condom in combination with vaginal spermicide).
- Participation in another clinical trial, currently or within 3 months prior to the screening visit.
- Liver failure (i.e. cirrhosis or active liver disease), diagnosed acute or chronic hepatitis regardless of cause.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dimethyl fumarate480 mg per day | Drug | Assessment of the degree of improvement in cognitive functions in diagnosed patients MCI and AD., Assessment of the impact of therapy on patients' daily functioning, Assessment of the impact of therapy on the presence of symptoms neuropsychiatric/behavioral disorder, Assessment of the safety of therapy, Effect of therapy on peripheral markers of oxidative stress and pro-inflammatory markers, degree of improvement in cognitive functions using the MMSE and CDR scales, degree of reduction in the rate of progression from MCI to dementia after completion, impact of therapy on improvement in functional connections assessed in rs-fMRI rs-EEG, reducing the degree of brain atrophy in patients - MRI examination |
Primary outcome
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.
Time frame: 15 months
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.
6 secondary outcomes
Assessment of the safety of therapy
Time frame: 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.
Time frame: 15 months
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).
Time frame: 15 months
Assessment of the impact of therapy on the quality of life of patients and their caregivers (EQ-5D scales; Zarit Burden Interview).
Time frame: 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).
Time frame: 6 months
Assessment of the effect of therapy on the improvement of functional connections assessed in rs-fMRI and rs-EEG.
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dimethyl fumarate in people with MCI and MCI-AD, Early Stage Alzheimer's Disease, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical University of Lodz Medical University of Lodz (+48 422725239, cwbk@umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.