Dataset Information

Sembragiline in Moderate Alzheimer's Disease: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Trial (MAyflOwer RoAD).

ABSTRACT:

Background

Sembragiline is a potent, selective, long-acting, and reversible MAO-B inhibitor developed as a potential treatment for Alzheimer's disease (AD).

Objective

To evaluate the safety, tolerability, and efficacy of sembragiline in patients with moderate AD.

Methods

In this Phase II study (NCT01677754), 542 patients with moderate dementia (MMSE 13-20) on background acetylcholinesterase inhibitors with/without memantine were randomized (1:1:1) to sembragiline 1 mg, 5 mg, or placebo once daily orally for 52 weeks.

Results

No differences between treated groups and placebo in adverse events or in study completion. The primary endpoint, change from baseline in ADAS-Cog11, was not met. At Week 52, the difference between sembragiline and placebo in ADAS-Cog11 change from baseline was - 0.15 (p = 0.865) and 0.90 (p = 0.312) for 1 and 5 mg groups, respectively. Relative to placebo at Week 52 (but not at prior assessment times), the 1 mg and 5 mg sembragiline groups showed differences in ADCS-ADL of 2.64 (p = 0.051) and 1.89 (p = 0.160), respectively. A treatment effect in neuropsychiatric symptoms (as assessed by the difference between sembragiline and placebo on BEHAVE-AD-FW) was also seen at Week 52 only: - 2.80 (p = 0.014; 1 mg) and - 2.64 (p = 0.019; 5 mg), respectively. A post hoc subgroup analysis revealed greater treatment effects on behavior and functioning in patients with more severe baseline behavioral symptoms (above the median).

Conclusions

This study showed that sembragiline was well-tolerated in patients with moderate AD. The study missed its primary and secondary endpoints. Post hoc analyses suggested potential effect on neuropsychiatric symptoms and functioning in more behaviorally impaired study population at baseline.

SUBMITTER: Nave S

PROVIDER: S-EPMC5523913 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

Sembragiline in Moderate Alzheimer's Disease: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Trial (MAyflOwer RoAD).

Nave Stephane S Doody Rachelle S RS Boada Mercè M Grimmer Timo T Savola Juha-Matti JM Delmar Paul P Pauly-Evers Meike M Nikolcheva Tania T Czech Christian C Borroni Edilio E Ricci Benedicte B Dukart Juergen J Mannino Marie M Carey Tracie T Moran Emma E Gilaberte Inma I Muelhardt Nicoletta Milani NM Gerlach Irene I Santarelli Luca L Ostrowitzki Susanne S Fontoura Paulo P

Journal of Alzheimer's disease : JAD 20170101 4

<h4>Background</h4>Sembragiline is a potent, selective, long-acting, and reversible MAO-B inhibitor developed as a potential treatment for Alzheimer's disease (AD).<h4>Objective</h4>To evaluate the safety, tolerability, and efficacy of sembragiline in patients with moderate AD.<h4>Methods</h4>In this Phase II study (NCT01677754), 542 patients with moderate dementia (MMSE 13-20) on background acetylcholinesterase inhibitors with/without memantine were randomized (1:1:1) to sembragiline 1 mg, 5 mg ...[more]

PMID: 28550255

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Dataset Information

Sembragiline in Moderate Alzheimer's Disease: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Trial (MAyflOwer RoAD).

Background

Objective

Methods

Results

Conclusions

Publications

Sembragiline in Moderate Alzheimer's Disease: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Trial (MAyflOwer RoAD).

Similar Datasets

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