Comparison of two nimodipine formulations in elderly patients with cognitive impairment randomized national multicentre double-blind

OBJECTIVE: To evaluate safety and effectiveness in cognitive decline in patients between 55 and 80 years of age, of two nimodipine formulations programed release, nimodipine 120 mg (PRN) in one daily dose, and conventional nimodipine 30 mg (CN) administered four times a day. METHODS: Study double blind, double dummy, random analytical in patients with a Mini Mental State Test (MMST) between 15 and 24. During the first 4 weeks, patients received placebo identical in appearance to the active drug in simple blind way. Following by a twelve-week double blind PHASE: a group with CN in four daily doses and placebo PRN and the other group with active SRN and placebo CN. Effectiveness and safety were evaluated treatment by changes in MMST, Barthel’s daily life scale, clinical impression of change scale by the physician and the patient. RESULTS: Of the 69 patients participating 66 (95.6%) successfully concluded the study of which 33 were treated with PRN and 33 with CN administered QID. In the CN group, 79% improved their MMST score, 78% reported improvement and in 84% improvement was observed by the physician. Five patients presented adverse effects (fainting, skin rash, headache and heartburn) of which two, had to stop treatment. In the PRN group, 94% patients improved their MMST SCORE: 94% reported improvement and in 91% improvement was observed by the physician. Three patients (9.1%) suffered adverse effects (heartburn, hypotension and dizziness), and one of them had to stop treatment. CONCLUSIONS: 120 mg. PRN administered once a day as well as 30 mg CN administered four times a day improve cognitive deterioration in elderly people, does not produce serious adverse effects and are well tolerated.