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COMPLETED
NCT07700615
PHASE4

Mexidol® Efficacy and Safety in Treatment of VCIND in Older Adults

Sponsor: Pharmasoft

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the efficacy of Mexidol® sequential parenteral and oral administration as part of comprehensive therapy in older adults with chronic brain ischemia and vascular cognitive impairment, no dementia (VCIND).

Official title: Open-label, Randomized, Comparative, Controlled Study of the Efficacy and Safety of Mexidol® Used as an Add-On to Standard Therapy in Older Adults With Vascular Cognitive Impairment, No Dementia

Key Details

Gender

All

Age Range

75 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-09-14

Completion Date

2025-11-05

Last Updated

2026-07-14

Healthy Volunteers

No

Interventions

DRUG

Mexidol

In addition to standard therapy, Mexidol sequential therapy was administered in two phases: * Days 1 to 5: Intravenous (IV) infusion of 10 mL (500 mg) once daily, diluted in 100-150 mL of 0.9% sodium chloride solution. Infusion rate: 40-60 drops per minute. * Days 6 to 65: Oral administration of Mexidol® FORTE 250 mg tablets, 1 tablet 3 times daily (750 mg total daily dose) for 60 consecutive days.

OTHER

Standard Therapy

Standard background therapy administered in accordance with institutional protocols and applicable clinical guidelines, including cognitive training.

Locations (4)

Ivanovo Regional Clinical Hospital

Ivanovo, Russia

Medinet, LLC

Saint Petersburg, Russia

City Hospital № 40 of Kurortny District

Saint Petersburg, Russia

Vsevolozhsk Clinical Interdistrict Hospital

Vsevolozhsk, Russia