Trial Profile
A Randomized Phase IIa, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety, Feasibility, Tolerability, and Efficacy of a New Buccal Film of Montelukast in Patients With Mild to Moderate Alzheimer's Disease
Status:
Active, no longer recruiting
Phase of Trial:
Phase II
Latest Information Update: 04 Aug 2023
Price :
$35
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At a glance
- Drugs Montelukast (Primary)
- Indications Alzheimer's disease
- Focus Proof of concept; Registrational; Therapeutic Use
- Acronyms BUENA
- Sponsors IntelGenx Corp.
- 01 Aug 2023 According to an IntelGenx Technologies media release, the company looking forward to completing the BUENA trial in the first quarter of 2024 and to reporting initial trial results the following quarter.
- 01 Aug 2023 Planned number of patients changed from 70 to 54.
- 01 Aug 2023 According to an IntelGenx Technologies media release, the enrollment for this study has been completed. The Company successfully enrolled 52 patients in the study, 18 fewer than initially planned. As the COVID-19 pandemic effectively halted recruitment for approximately 18 months, followed by imposed post-pandemic restrictions from hospitals, the company's rationale behind decreasing study enrollment was to avoid any further delay in achieving the program's goal.