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

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 [chromoglicic acid] + ALZT-OP1b [ibuprofen]) will slow down, arrest, or reverse cognitive and functional decline, in subjects with evidence of early stage Alzheimer's disease (AD).

Study Type: Interventional

Study Design: Allocation: Randomized

Endpoint Classification: Safety/Efficacy Study

Intervention Model: Factorial Assignment

Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary Purpose: Treatment

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

Estimated Enrollment: 600

Study Start Date: September 2015

Estimated Study Completion Date: March 2018

Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Arms:

Active Comparator: Group I, ALZT-OP1a active capsules for inhalation and ALZT-OP1b placebo capsules for oral administration.

Active Comparator: Group II, ALZT-OP1a active capsules for inhalation and ALZT-OP1b active tablets for oral administration.

Active Comparator: Group III, ALZT-OP1a placebo capsules for inhalation and ALZT-OP1b active tablets for oral administration.

Placebo Comparator: Group IV, ALZT-OP1a placebo capsules for inhalation and ALZT-OP1b placebo tablets for oral administration.