Multicenter Randomized Double-blind Placebo-controlled Three-arm Parallel-group Clinical Study to Evaluate the Efficacy and Safety of DMB-I in the Treatment of Dementia Associated With Alzheimer's Disease

Bigespas LTD7 sites in 1 country133 target enrollmentDecember 27, 2023

ConditionsAlzheimer Disease Dementia of Alzheimer Type

InterventionsDMB-I (Dimebon)Placebo

DrugsDMB-I (Dimebon)

Overview

Phase: Phase 2
Intervention: DMB-I (Dimebon)
Conditions: Alzheimer Disease
Sponsor: Bigespas LTD
Enrollment: 133
Locations: 7
Primary Endpoint: 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
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the efficacy and safety of DMB-I for the treatment of patients with Alzheimer type dementia.

Detailed 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: 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.

Registry

clinicaltrials.gov

Start Date

December 27, 2023

End Date

January 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bigespas LTD

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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 neuroimaging signs of vascular dementia.
•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.
•Patients who are able to undergo the tests provided for in the protocol.

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:
•Respiratory system disorders;
•Cardiovascular system disorders;
•Severe renal impairment (glomerular filtration rate \<30ml/min);

Arms & Interventions

DMB-I (Dimebon) + Placebo

Intervention: DMB-I (Dimebon)

DMB-I (Dimebon) + Placebo

Intervention: Placebo

DMB-I (Dimebon)

Intervention: DMB-I (Dimebon)

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: Baseline (Visit 0) and 26 weeks (Visit 6)

The scale's minimum score - 0, maximum score - 82, where the higher score means the worse outcome

Secondary Outcomes

Mean change in cognitive impairment score on the Alzheimer's Disease Assessment Scale after 12 weeks of therapy compared to baseline(Baseline (Visit 1) and 12 weeks of therapy (Visit 4))
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)(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)(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)(Baseline (Visit 1), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6))
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)(Baseline (Visit 0), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6))