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

(COGNITE Trial)

Recruiting in Palo Alto (17 mi)

+122 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AZTherapies, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Research Team

David R. Elmaleh, PhD

Principal Investigator

AZTherapies, Inc.

Eligibility Criteria

Inclusion Criteria

55-79 years old;

≥ 8 years of education;

Study partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to all clinic visits for the duration of the protocol;

Treatment Details

Interventions

• ALZT-OP1a (Other)
• ALZT-OP1b (Other)

Participant Groups

Group I: Group II Active Control 2 Interventions

ALZT-OP1a active capsules for inhalation and ALZT-OP1b active tablets for oral administration.

Group II: Group III Active Control 2 Interventions

ALZT-OP1a placebo capsules for inhalation and ALZT-OP1b active tablets for oral administration.

Group III: Group I Active Control 2 Interventions

ALZT-OP1a active capsules for inhalation and ALZT-OP1b placebo capsules for oral administration.

Group IV: Group IV Placebo Group 2 Interventions

ALZT-OP1a placebo capsules for inhalation and ALZT-OP1b placebo tablets for oral administration.

Who Is Running the Clinical Trial?

AZTherapies, Inc.

Lead Sponsor

Trials

5

Recruited

710+

APCER Life Sciences

Collaborator

Trials

3

Recruited

1,100+

PharmaConsulting Group

Collaborator

Trials

1

Recruited

620+

KCAS Bio

Collaborator

Trials

2

Recruited

780+