Phase 2, Multi center, double-blind, placebo-controlled adaptive study to assess the efficacy and safety of a new buccal film of montelukast in patients with moderate Alzheimer’s disease
What is this Study about?
This is a randomized Phase IIa, multi-center, double-blind, placebo-controlled study of a new buccal film of montelukast in patients with mild to moderate Alzheimer's Disease.
What Will Happen in This Study?
For a treatment period of 26 weeks, participants will receive Montelukast buccal film to administer once or twice daily inside of the cheek.
Who is Eligible to Participate in this Study?
- Age 50+ years
- MMSE score of 14-22 at screening
- CT or MRI within 18 months prior to screening indicating clinical phenotype of Alzheimer’s Disease
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