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DMB‑I (latrepirdine) treatment for Alzheimer type dementia

Multicenter Randomized Double-blind Placebo-controlled Active Comparator-controlled Study to Assess the Efficacy and Safety of DMB-I (Dimebon®, INN: Latrepirdine) in Patients With Dementia Associated With Alzheimer's Disease

PHASE3 · Bigespas LTD · NCT07251023

This 26‑week test looks at whether DMB‑I (latrepirdine), given alone or with memantine, helps adults aged 60–90 with mild to moderate Alzheimer type dementia compared with a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment450 (estimated)
Ages60 Years to 90 Years
SexAll
SponsorBigespas LTD (industry)
Locations12 sites (Kazan' and 11 other locations)
Trial IDNCT07251023 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double‑blind, placebo‑controlled two‑stage Phase 3 trial conducted at about 15 sites in the Russian Federation. In Stage 1 (26 weeks) participants are randomized to one of three groups: DMB‑I plus memantine, placebo plus memantine, or DMB‑I alone, with DMB‑I/placebo blinded and memantine unblinded. After Stage 1 all participants enter a 26‑week open‑label Stage 2 during which placebo recipients switch to DMB‑I to evaluate longer‑term safety and efficacy. Participants attend 13 clinic visits, keep a symptom diary, and have regular safety and cognitive assessments including MMSE and ADAS‑Cog.

Who should consider this trial

Good fit: Ideal candidates are adults aged 60–90 with mild to moderate Alzheimer type dementia (MMSE 10–23, ADAS‑Cog 20–54) who have a caregiver and, for the memantine arms, have been on memantine 20 mg daily for at least two months.

Not a fit: Patients with significant vascular dementia signs on imaging, a Modified Hachinski Ischemic Scale score ≥7, MMSE or ADAS‑Cog scores outside the specified ranges, or who cannot attend the required clinic visits or provide a caregiver are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, DMB‑I could improve cognitive symptoms or slow cognitive decline in people with mild to moderate Alzheimer type dementia.

How similar studies have performed: Earlier small trials of latrepirdine reported positive signals but larger subsequent Phase 3 trials largely failed to confirm clear clinical benefit.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Inclusion Criteria (Group 1 and Group 2):

  1. Informed consent to participate in the study.
  2. Patients of any gender aged 60 to 90 years inclusive.
  3. 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.
  4. The MMSE score is in the range of 10-23 inclusive.
  5. The ADAS-Cog score is in the range of 20-54 inclusive.
  6. 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.
  7. The Modified Hachinski Ischemic Scale (HIS) score is \< 7.
  8. 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.
  9. An ability to comply with all Protocol requirements.
* Inclusion Criteria (Group 3):

  1. Informed consent to participate in the study.
  2. Patients of any gender aged 60 to 90 years inclusive.
  3. 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 screening or for the last two (or more) months prior to screening; however, taking such medications for more than two months prior to screening does not limit a patient's participation in the study.
  4. The MMSE score is in the range of 10-23 inclusive.
  5. The ADAS-Cog score is in the range of 20-54 inclusive.
  6. 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.
  7. The Modified Hachinski Ischemic Scale (HIS) score is \< 7.
  8. 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.
  9. An ability to comply with all Protocol requirements.

Exclusion Criteria:

1. Patients diagnosed with other diseases that cause dementia (severe hypothyroidism, anemia, brain tumor, neuroinfections, etc.) at screening.
2. 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.
3. History of intolerance to any of the components of the study drug.
4. History of stroke.
5. Active oncological process.
6. The need for surgeries on the vessels of the neck or brain, including endovascular interventions, during the study.
7. 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.
8. Systemic autoimmune diseases or vascular collagenoses requiring previous or current treatment with systemic drugs.
9. Myocardial infarction within 12 months prior to screening.
10. Known systemic infection (viral hepatitis, HIV, tuberculosis, syphilis).
11. Life expectancy less than a year after randomization.
12. 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) within 1 month prior to screening.
13. Moderate to severe depression (Hamilton scale score of 18 or more).
14. Smoking.
15. Episodes of alcohol or drug abuse within the last 6 months.
16. Inability to comply with study procedures even with the assistance, in the opinion of the investigator.
17. Participation in another clinical trial within the last 6 months.
18. 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 ability to participate in the trial.

Where this trial is running

Kazan' and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Alzheimer Type Dementia

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.