DMB-I in the Treatment of Alzheimer Type Dementia

NCT06292351 | Completed Phase 2

• 1 other identifier: DMBN_ALZH-2022-II
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 7

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.

Conditions

Alzheimer Disease; Dementia of Alzheimer Type

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline (Visit 0) and 26 weeks (Visit 6)

Secondary Outcomes (5)

• 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)

• 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)

• 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)

Study Arms (3)

DMB-I (Dimebon) + Placebo

EXPERIMENTAL

Drug: DMB-I (Dimebon); Other: Placebo

DMB-I (Dimebon)

EXPERIMENTAL

Drug: DMB-I (Dimebon)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

DMB-I (Dimebon) DRUG

20 mg 3 times a day, or 10 mg + 10 mg 3 times a day (for DMB-I + Placebo arm)

DMB-I (Dimebon); DMB-I (Dimebon) + Placebo

Placebo OTHER

20 mg 3 times a day, or 10 mg + 10 mg 3 times a day (for DMB-I + Placebo arm)

DMB-I (Dimebon) + Placebo; Placebo

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.
• 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

Sponsors & Collaborators

• Bigespas LTD: lead

Study Sites (7)

State autonomous healthcare institution "Transregional Clinical Diagnostic Center"

Kazan', 420101, Russia

Location

Federal State Budgetary Institution "Federal center for brain and neurotechnologies" of the Federal Medical and Biological Agency (FSBI "FCBN" of Russia's FMBA)

Moscow, 117997, Russia

Location

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, 119991, Russia

Location

State public healthcare institution Leningrad regional psychoneurologic dispensary

Roshchino, 188820, Russia

Location

"Medical Center Nova Vita"

Rostov-on-Don, 344082, Russia

Location

Saint Petersburg State budgetary healthcare institution "City Hospital № 40 of Kurortniy district"

Saint Petersburg, 197706, Russia

Location

"Centre of evidence-based medicine" LLC

Yaroslavl, 150000, Russia

Location

Related Links

• Differences in bioavailability and cognitive-enhancing activity exerted by different crystal polymorphs of latrepirdine (Dimebon®)

MeSH Terms

Conditions

Alzheimer Disease

Interventions

latrepirdine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: December 27, 2023
• Primary Completion: January 13, 2025
• Study Completion: January 31, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

RU (7)