MIND

CompletedPhase 3

Local Study of Akatinol Memantine in VaD in Russia

Multi-center Open Comparative Randomized Study of Efficacy and Safety of Akatinol Memantine 20 mg (Single-doses) vs. Akatinol Memantine 10 mg (Double-doses) in Patients With Moderate and Moderately Severe Vascular Dementia

Lead sponsor

Merz Pharmaceuticals GmbH

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

130

actual

Study population

Vascular cognitive impairment / dementia

Key I/E criteria

•Vascular dementia•MMSE 10-20

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDM900011005

NCT IDNCT03986424

Timeline

Milestones

Study start2018-01-23actual

Study first posted2019-06-14actual

Primary completion2022-06-01actual

Study completion2022-06-01actual

Last update posted2022-07-22actual

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Written informed consent obtained from the patient or his/her legal representative if the patient is declared incapable by a court decision.

•Understanding of study procedures and willingness to abide to all procedures during the course of the study by the patient or his/her legal representative.

•Male and female patients from 50 to 85 years of age (inclusive) suffering from moderate and moderately severe vascular dementia.

•Mini-Mental State Examination (MMSE) Test total scores of 10 to 20.

•Hachinski's Ischemic Score (HIS) of 7 or higher point.

•Availability in the anamnesis of instrumental confirmation of the diagnosis (data methods of neurovisualization - CT or MRT).

•For females: menopause or inability to conceive due to other reasons (hysterectomy, etc.).

•Availability of a relative or legal representative who lives with the patient, monitors him/her and cares for the patient

Exclusion criteria

•Alzheimer's disease or secondary types of dementia.

•Epilepsy, seizures, schizophrenia, other psychoses, bipolar disorder, alcoholism, drug abuse (including the history thereof).

•Other clinically significant neurological or psychiatric disorders.

•Severe depression (Hamilton score, HAM-D > 18 points).

•Severe, unstable or decompensated physical disease (including clinically significant laboratory abnormalities) potentially affecting the trial findings.

•Contraindications to oral drug intake during the time period determined by the study protocol.

•Known hypersensitivity to the investigational product or any of its ingredients.

•Administration of nootropic, anti-dementia and typical antipsychotic drugs, tricyclic antidepressants, long-acting benzodiazepines, NMDA receptor antagonists (amantadine, ketamine, dextromethorphan) for 1 month before the enrollment and during the study.

•For females: pregnancy and breastfeeding.

•Evidence or suspicion that the patient might not comply with the study directive.

•Any reason or contraindication which in the investigator's opinion precludes participation in the study.

•Patient is direct relative of an employee of the study site or Merz Pharma LLC.

•Previous participation in this clinical study.

•Participation in another clinical trial within the last 12 weeks prior to screening or ongoing participation in a study.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

1 endpoint

Primary/protocol endpoint

Change from baseline in total ADAS-cog score points

Time frame:24 weeks

ADAS-Cog

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.