Status and phase
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About
The purpose of this study is to assess the efficacy and safety of DMB-I for the treatment of patients with Alzheimer type dementia.
Full description
This is a multicenter, randomized, placebo-controlled study that is to assess efficacy and safety, to select the optimal therapeutic dose of the drug and to test the hypothesis of superiority of DMB-I (Dimebon) over placebo in patients with mild to moderate Alzheimer's disease.
The study is planned to be conducted in clinical sites of the Russian Federation.
Patients meeting all the eligibility criteria will be randomized into one of three treatment arms:
The total study duration for each patient is approximately 182 days broken down as follows:
Screening period: up to 14 days, Treatment period: 26 weeks, Follow-up period: 2 weeks.
Enrollment
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Inclusion criteria
Exclusion criteria
Patients diagnosed with other diseases that cause dementia (severe hypothyroidism, anemia, brain tumor, including a history of neuroinfections, etc.) according to medical history, medical documentation and the results of additional examination methods.
History of other neurodegenerative diseases of the brain, Parkinson's disease, multiple sclerosis, demyelinating diseases of the nervous system, hereditary degenerative diseases of the central nervous system, abnormalities of the nervous system, uncontrolled epilepsy, hallucinations, other neurological disorders seriously affecting motor or cognitive function, in the opinion of the investigator.
History of intolerance to any of the components of the study drug.
History of stroke.
Active oncological process.
The need for surgeries on the vessels of the neck or brain, including endovascular interventions, during the study.
Signs of significant uncontrolled concomitant disease that, in the opinion of the Investigator, could prevent the patient from participating in the study, including:
Systemic autoimmune diseases or vascular collagenoses requiring previous or current treatment with systemic drugs.
Use of drugs that negatively affect cognitive function (tricyclic antidepressants, benzodiazepines, antipsychotics, hypnotics, etc.), as well as drugs of prohibited therapy (including Cerebrolysin, preparations of ginkgo biloba extract, any other drugs with nootropic, antioxidant, metabolic effects, as well as drugs used to treat dementia). Situational use of psychotropic drugs (e.g., for the treatment of insomnia, or to relieve agitation and anxiety) is permitted
Moderate to severe depression (Hamilton scale score of 14 or more).
Smoking.
Episodes of alcohol or drug abuse within the last 6 months.
Inability to comply with study procedures even with the assistance, in the opinion of the investigator.
Episodes of other serious or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological disorders.
Myocardial infarction within 12 months prior to screening.
Known systemic infection (viral hepatitis, HIV, tuberculosis, syphilis).
Life expectancy less than 26 weeks after randomization.
Men of reproductive potential who are unwilling to use adequate contraceptive methods.
Participation in another clinical trial within the last 6 months.
Primary purpose
Allocation
Interventional model
Masking
133 participants in 3 patient groups, including a placebo group
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Central trial contact
Yana Shabalina
Data sourced from clinicaltrials.gov
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