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Tests treatment safety and results for Alzheimer Type Dementia
Official title Efficacy and Safety of DMB-I (INN: Latrepirdine) in Patients With Alzheimer Type Dementia
ClinicalTrials.gov ID: NCT07251023
What this study is testing
What is DMB-I (INN: Latrepirdine)?
DMB-I (INN: Latrepirdine) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alzheimer type dementia.
Also referred to as Latrepirdine, Dimebon®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical study is to learn if the study drug DMB-I (INN: Latrepirdine) works to treat Alzheimer type dementia in adults. It will also learn about the safety of DMB-I (INN: Latrepirdine).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 90
You may be able to join if
- (Group 1 and Group 2):
- Informed consent to participate in the study.
- Patients of any gender aged 60 to 90 years inclusive.
- Patients diagnosed with mild to moderate Alzheimer type dementia according to the NINCDS-ADRDA criteria, receiving basic treatment with memantine at...
- The MMSE score is in the range of 10-23 inclusive.
You likely can't join if
- Patients diagnosed with other diseases that cause dementia (severe hypothyroidism, anemia, brain tumor, neuroinfections, etc.) at screening.
- History of other neurodegenerative diseases of the brain, Parkinson's disease, multiple sclerosis, demyelinating diseases of the nervous system...
- 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.
See the full eligibility criteria
- (Group 1 and Group 2):
- Informed consent to participate in the study.
- Patients of any gender aged 60 to 90 years inclusive.
- Patients diagnosed with mild to moderate Alzheimer type dementia according to the NINCDS-ADRDA criteria, receiving basic treatment with memantine at a daily dose of 20 mg for at least 2 months.
- The MMSE score is in the range of 10-23 inclusive.
- The ADAS-Cog score is in the range of 20-54 inclusive.
- No signs of dementia of vascular origin according to CT/MRI data. Repeated Acute Cerebrovascular Accidents (focal infarctions) in brain areas that are critical for cognitive functions and behavior are the mandatory...
- The Modified Hachinski Ischemic Scale (HIS) score is \< 7.
- The presence of a caregiver who is in contact with the patient a significant part of the time, agrees to accompany the patient to all visits, monitor the intake of the study drug and fill out the patient's diary.
- An ability to comply with all Protocol requirements.
- (Group 3):
- Informed consent to participate in the study.
- Patients of any gender aged 60 to 90 years inclusive.
- Patients diagnosed with mild to moderate Alzheimer type dementia according to the NINCDS-ADRDA criteria, who are not receiving dementia-contolling medications (memantine, donepezil, rivastigmine, or galantamine) at...
- The MMSE score is in the range of 10-23 inclusive.
- The ADAS-Cog score is in the range of 20-54 inclusive.
- No signs of dementia of vascular origin according to CT/MRI data. Repeated Acute Cerebrovascular Accidents (focal infarctions) in brain areas that are critical for cognitive functions and behavior are the mandatory...
- The Modified Hachinski Ischemic Scale (HIS) score is \< 7.
- The presence of a caregiver who is in contact with the patient a significant part of the time, agrees to accompany the patient to all visits, monitor the intake of the study drug and fill out the patient's diary.
- An ability to comply with all Protocol requirements.
- Patients diagnosed with other diseases that cause dementia (severe hypothyroidism, anemia, brain tumor, neuroinfections, etc.) at screening.
- 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...
- 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:
- Respiratory system disorders;
- Cardiovascular system disorders;
- Severe renal impairment (glomerular filtration rate \<30ml/min);
- Severe liver dysfunction (ALT, AST \> 2 times the upper limit of normal);
- Endocrine system disorders;
- Gastrointestinal disorders.
- Systemic autoimmune diseases or vascular collagenoses requiring previous or current treatment with systemic drugs.
- Myocardial infarction within 12 months prior to screening.
- Known systemic infection (viral hepatitis, HIV, tuberculosis, syphilis).
- Life expectancy less than a year after randomization.
- 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...
- Moderate to severe depression (Hamilton scale score of 18 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.
- Participation in another clinical trial within the last 6 months.
- Episodes of other serious or unstable psychiatric conditions that make the patient unsuitable for participation in a clinical study, alter the validity of obtaining an informed consent, or may affect the patient's...
The study team makes the final eligibility decision.
Where it's taking place
- Kazan', Russia
- Moscow, Russia
- Nizhny Novgorod, Russia
- Roshchino, Russia
- Rostov-on-Don, Russia
- Saint Petersburg, Russia
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, 60 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kazan', Russia; Moscow, Russia; Nizhny Novgorod, Russia; Roshchino, Russia; Rostov-on-Don, Russia; Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.