Study to Evaluate the Safety and Effectiveness of Latrepirdine DMB-I in Adults Aged 60 to 90 With Alzheimer Type Dementia

What this Trial Is About

This research aims to evaluate whether the study drug DMB-I INN Latrepirdine can improve cognitive functions in adults with Alzheimer type dementia and to assess its safety. The study also compares DMB-I to a placebo to understand its effects better, including when taken long-term. It involves patients aged 60 to 90 years diagnosed with mild to moderate Alzheimers type dementia. The study is a multicenter, randomized, double-blind, placebo-controlled trial with two treatment stages lasting 26 weeks each. In Stage 1, participants are assigned to one of three groups DMB-I alone, DMB-I plus Akatinol Memantine4, or placebo plus Akatinol Memantine4. After Stage 1, all groups continue for another 26 weeks in an open-label phase where some treatments may change. The total study duration per participant is about 56 weeks including screening and follow-up periods. Participants will visit the clinic 13 times for checkups and tests, and keep a diary of their symptoms. Researchers will measure changes in cognitive function using the ADAS-Cog scale at multiple time points up to week 52, comparing scores to baseline. Safety and long-term effects of DMB-I will also be monitored. Follow-up visits occur after treatment to assess ongoing health and outcomes.

Efficacy and Safety of DMB-I (INN: Latrepirdine) in Patients With Alzheimer Type Dementia