The purpose of this study is to assess the efficacy and safety of DMB-I for the treatment of patients with Alzheimer type dementia.
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: 1. DMB-I (Dimebon) 1 tab + Placebo 1 tab 3 times a day. 2. DMB-I (Dimebon) 2 tab 3 times a day. 3. Placebo 2 tab 3 times a day. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
133
20 mg 3 times a day, or 10 mg + 10 mg 3 times a day (for DMB-I + Placebo arm)
20 mg 3 times a day, or 10 mg + 10 mg 3 times a day (for DMB-I + Placebo arm)
State autonomous healthcare institution "Transregional Clinical Diagnostic Center"
Kazan', Russia
Federal State Budgetary Institution "Federal center for brain and neurotechnologies" of the Federal Medical and Biological Agency (FSBI "FCBN" of Russia's FMBA)
Moscow, Russia
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
Mean change in Alzheimer's Disease Assessment Scale score after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0) in patients receiving the study drug or placebo
The scale's minimum score - 0, maximum score - 82, where the higher score means the worse outcome
Time frame: Baseline (Visit 0) and 26 weeks (Visit 6)
Mean change in cognitive impairment score on the Alzheimer's Disease Assessment Scale after 12 weeks of therapy compared to baseline
The scale's minimum score - 0, maximum score - 82, where the higher score means the worse outcome
Time frame: Baseline (Visit 1) and 12 weeks of therapy (Visit 4)
Mean change in Mini-Mental State Examination score after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0)
The min/max score values are 0/30 respectively, where the higher score means the better outcome
Time frame: Baseline (Visit 0), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6)
Change in the quality of life of patients according to the Quality of Life - Alzheimer's Disease questionnaire after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1)
The scale has 13 items, that may be evaluated on 13-52 points, where the higher score means the better outcome
Time frame: Baseline (Visit 1), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6)
Change in the general clinical impression in accordance with the Clinical Global Impressions Scale after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1)
The scale consists of 3 blocks, which may be evaluated on 0 to 7 points for each of the first two blocks, and on 1 to 16 points for the third block. The higher score means the worse outcome.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
State public healthcare institution Leningrad regional psychoneurologic dispensary
Roshchino, Russia
"Medical Center Nova Vita"
Rostov-on-Don, Russia
Saint Petersburg State budgetary healthcare institution "City Hospital № 40 of Kurortniy district"
Saint Petersburg, Russia
"Centre of evidence-based medicine" LLC
Yaroslavl, Russia
Time frame: Baseline (Visit 1), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6)
Dynamics on the Lawton's Instrumental activities of daily living scale after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1)
The min/max score values are 0/8 respectively, where the higher score means the worse outcome
Time frame: Baseline (Visit 1), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6)