Actively Recruiting
Efficacy and Safety of DMB-I (INN: Latrepirdine) in Patients With Alzheimer Type Dementia
Led by Bigespas LTD · Updated on 2025-12-10
450
Participants Needed
12
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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). The main questions it aims to answer are: * Does DMB-I improve cognitive functions in patients with dementia associated with Alzheimer's disease, and how sigificant the improvement is? * What medical problems do participants have when taking DMB-I? Researchers will compare DMB-I to a placebo (a look-alike substance that contains no drug) to see if the study drug works to treat Alzheimer type dementia. * Is DMB-I effective and safe when taken long-term? Participants will: Take the study drug or a placebo (with or without Akatinol Memantine®) every day for 26 weeks at Stage 1 of the study, and take the study drug (with or without Akatinol Memantine®) every day for 26 weeks at Stage 2 of the study. Visit the clinic 13 times for checkups and tests Keep a diary of their symptoms
CONDITIONS
Official Title
Efficacy and Safety of DMB-I (INN: Latrepirdine) in Patients With Alzheimer Type Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent to participate in the study
- Be aged between 60 and 90 years inclusive
- Have a diagnosis of mild to moderate Alzheimer type dementia by NINCDS-ADRDA criteria
- For Groups 1 and 2: Be treated with memantine 20 mg daily for at least 2 months
- Have a Mini-Mental State Examination (MMSE) score between 10 and 23 inclusive
- Have an Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) score between 20 and 54 inclusive
- Show no signs of vascular dementia on CT/MRI scans
- Have a Modified Hachinski Ischemic Scale score less than 7
- Have a caregiver who spends significant time with the patient and agrees to assist throughout the study
- Be able to follow all study protocol requirements
- For Group 3: Not be receiving dementia-controlling medications (memantine, donepezil, rivastigmine, galantamine) at or within 2 months before screening, but prior use over 2 months before screening is allowed
You will not qualify if you...
- Diagnosis of other causes of dementia such as severe hypothyroidism, anemia, brain tumor, or neuroinfections
- History of other neurodegenerative brain diseases, Parkinson's, multiple sclerosis, demyelinating diseases, hereditary CNS disorders, uncontrolled epilepsy, hallucinations, or other serious neurological disorders
- History of intolerance to any study drug components
- History of stroke
- Active cancer
- Need for neck or brain vessel surgery or endovascular interventions during the study
- Significant uncontrolled diseases affecting respiratory, cardiovascular, renal (GFR <30 ml/min), liver (ALT, AST >2x normal), endocrine, or gastrointestinal systems
- Systemic autoimmune diseases or vascular collagenoses requiring systemic treatment
- Myocardial infarction within 12 months prior to screening
- Known systemic infections like hepatitis, HIV, tuberculosis, or syphilis
- Life expectancy less than one year after randomization
- Use of drugs negatively affecting cognition or prohibited therapies within 1 month before screening
- Moderate to severe depression (Hamilton scale score 18 or more)
- Smoking
- Alcohol or drug abuse episodes within the last 6 months
- Inability to comply with study procedures even with assistance
- Participation in another clinical trial within the last 6 months
- Serious or unstable psychiatric conditions affecting consent or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
State autonomous healthcare institution "Transregional Clinical Diagnostic Center"
Kazan', Russia, 420101
Actively Recruiting
2
Moscow State budgetary healthcare institution "City Clinical Hospital named after V.M. Buyanov of the Moscow Healthcare Department"
Moscow, Russia, 115516
Actively Recruiting
3
Federal State Budgetary Institution "Federal Center for Brain and Neurotechnology" of the Federal Medical and Biological Agency
Moscow, Russia, 117513
Actively Recruiting
4
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Moscow, Russia, 119991
Actively Recruiting
5
Nizhny Novgorod region State budgetary healthcare institution " Nizhny Novgorod Clinical Psychiatric Hospital No. 1"
Nizhny Novgorod, Russia, 603155
Actively Recruiting
6
State budgetary healthcare institution "Leningrad Regional Mental Health Center"
Roshchino, Russia, 188820
Actively Recruiting
7
"Medical Center Nova Vita" LLC
Rostov-on-Don, Russia, 344082
Actively Recruiting
8
Saint Petersburg State budgetary healthcare institution "Psychiatric Hospital No. 1 named after P.P. Kashchenko"
Saint Petersburg, Russia, 188357
Actively Recruiting
9
"Medical services" LLC
Saint Petersburg, Russia, 194356
Actively Recruiting
10
Saint Petersburg State budgetary healthcare institution "Psychoneurologic dispensary № 5"
Saint Petersburg, Russia, 195176
Actively Recruiting
11
"Sphera Med" LLC
Saint Petersburg, Russia, 197342
Actively Recruiting
12
Saint Petersburg State budgetary healthcare institution "City Hospital No. 40 of Kurortniy district"
Saint Petersburg, Russia, 197706
Actively Recruiting
Research Team
A
Anna Rashina
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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