BridgeMD
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
EU CTIS ID: 2024-517214-16-00
What this study is testing
Assessment of the degree of improvement in cognitive functions, including memory, attention, thinking, executive and language functions in patients diagnosed with MCI and AD receiving dimethyl fumarate at a dose of 480 mg daily compared to patients taking placebo
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men and women aged 55-90.
- Patients diagnosed with mild cognitive impairment in Alzheimer's disease and mild to moderate dementia in Alzheimer's disease (MMSE> 16) diagnosed according to NIA-AA criteria.
- MMSE score from 17 to 30 points.
- CDR score from 0.5 to 2.
- Signing by the patient of informed, voluntary consent to participate in the study.
- The patient has a close person / actual guardian who agrees to help the patient during the participation in the study.
You likely can't join if
- Lack of informed consent to participate in the study.
- 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 MRI haemorrhagic foci ≥ 2 cm3 in diameter, more than three (3) ischemic foci ≥ 1.5 cm3 in diameter or a single ischemic focus ≥ 2 cm3, presence of vascular malformations, aneurysms, subdural hematoma, normotensive hydrocephalus, the final decision is at the discretion of the researcher.
- Severe or uncontrolled physical disease that could interfere with the course of the study (e.g., cancer, cardiovascular, respiratory, metabolic or digestive, severe renal failure, unstable type I or II diabetes, untreated or uncontrolled clinically significant arterial hypertension) .
See the full eligibility criteria
Who can join
- Men and women aged 55-90.
- Patients diagnosed with mild cognitive impairment in Alzheimer's disease and mild to moderate dementia in Alzheimer's disease (MMSE> 16) diagnosed according to NIA-AA criteria.
- MMSE score from 17 to 30 points.
- CDR score from 0.5 to 2.
- Signing by the patient of informed, voluntary consent to participate in the study.
- The patient has a close person / actual guardian who agrees to help the patient during the participation in the study.
- Minimum 6 years of education.
- For anti-Alzheimer's drugs, cholinesterase inhibitors are acceptable were included at least 3 months prior to study inclusion and used at a stable dose for at least 60 days prior to study inclusion. For memantine, its use is acceptable when it is included at least 4 months prior to study inclusion and used at a stable dose for at least 3 months prior to study inclusion.
What rules you out
- Lack of informed consent to participate in the study.
- 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 MRI haemorrhagic foci ≥ 2 cm3 in diameter, more than three (3) ischemic foci ≥ 1.5 cm3 in diameter or a single ischemic focus ≥ 2 cm3, presence of vascular malformations, aneurysms, subdural hematoma, normotensive hydrocephalus, the final decision is at the discretion of the researcher.
- Severe or uncontrolled physical disease that could interfere with the course of the study (e.g., cancer, cardiovascular, respiratory, metabolic or digestive, severe renal failure, unstable type I or II diabetes, untreated or uncontrolled clinically significant arterial hypertension) .
- Use of benzodiazepines or barbiturates one week prior to screening.
- Pharmacological immunosuppression.
- Patients with bipolar disorder or psychotic disorder or any other psychiatric condition (current or past) that the Investigator considers to be interfering with the study.
- Alcoholism, benzodiazepine dependence or drug dependence as defined by DSM-5 in the last 5 years (addicted for more than one year and or in remission for less than 3 years).
- Patients with any medical condition that the investigator considers to be an exclusion criterion.
- Inability to read or write.
- Treatment with thyroid hormones started, stopped or modified within the 3 months prior to the selection visit.
- Treatment of menopause with hormone replacement therapy, started, stopped or modified within the 3 months prior to the screening visit.
- Use of drugs not allowed in the study (each time to be decided by the investigator): immunosuppressive anticancer agents, immunosuppressants, ethyl ester corticosteroids applied orally or topically and live attenuated vaccines. Inactivated vaccines can be used.
- Women who are pregnant, breastfeeding or of childbearing age not using effective contraception (hormonal contraception, surgical sterilization, intrauterine device, condom in combination with vaginal spermicide).
- Participation in another clinical trial, currently or within 3 months before the screening visit.
- Liver failure (ie cirrhosis or active liver disease), diagnosed acute or chronic hepatitis, regardless of the cause.
- Chronic kidney disease with elevated serum creatinine value > 115umol/l (1,3 mg/dL).
- Abnormal results of hepatic parameters: ALT> 2 times upper limit of normal,
- Leukopenia (<4000 / mm3), granulocytopenia (<1500 / mm3) or lymphopenia (<1000 / mm3) from any cause.
- Severe agitation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.