NCT02547818

Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease

A Phase III Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 620 (actual)
• Sponsor: AZTherapies, Inc. · Industry
• Sex: All
• Age: 55 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This is a global Phase III, randomized, double-blinded, placebo-controlled study for subjects with evidence of early AD. The protocol is designed to determine whether ALZT-OP1 combination treatment (ALZT-OP1a + ALZT-OP1b) will slow down, arrests, or reverse cognitive and functional decline, in subjects with evidence of early stage Alzheimer's disease (AD).

Detailed description

This Phase III study is designed as a randomized, double-blinded, placebo-controlled study for subjects with evidence of early AD. The study will evaluate safety and tolerability, efficacy as measured by CDR-SB, and will determine if the combination therapy ALZT-OP1 will slow down, arrests, or reverse cognitive and functional decline in an early stage AD population. Subjects will be randomly assigned to one of four treatment arms: Group I will consist of ALZT-OP1a (cromolyn) for inhalation, plus an oral placebo tablet; OR the Group II arm, which will consist of ALZT-OP1 combination therapy ALZT-OP1a (cromolyn) for inhalation, plus ALZT-OP1b (ibuprofen) tablet for oral administration; OR to the Group III arm, which will consist of inhaled placebo, plus ALZT-OP1b (ibuprofen) tablet for oral administration; OR to the Group IV placebo arm, which will consist of inhaled placebo plus an oral placebo tablet. A minimum of 400 evaluable subjects will be randomized to receive one of four possible treatment assignments containing various combinations of active study drug or placebo. To account for subject dropouts (estimated rate of 30%), it is anticipated that up to 600 (or 150 subjects per treatment arm) may be recruited and randomized, to achieve a minimum of 100 evaluable subjects per treatment arm.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	ALZT-OP1a	1\) Mast cell stabilizer, 2) Neuroinflammatory microglial modulator, 3) A-beta oligomerization inhibitor, and 4) anti-inflammatory
DRUG	ALZT-OP1b	Anti-inflammatory
OTHER	Placebo ALZT-OP1a	Non-active capsules
OTHER	Placebo ALZT-OP1b	Non-active tablets

Timeline

• Start date: 2015-09-15
• Primary completion: 2020-11-13
• Completion: 2020-11-18
• First posted: 2015-09-11
• Last updated: 2021-11-10

Locations

121 sites across 7 countries: United States, Australia, Bulgaria, Canada, Czechia, Hungary, Poland