Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title: A Phase I/II Randomized, Open-Labeled Study to Evaluate Pharmacokinetic and Pharmacodynamic Effects and Safety of ALZT-OP1 in Subjects With Alzheimer's Disease and Normal Healthy Volunteers

Status Completed

Clinical Trial Summary

This is a randomized, open-label, cross-over, pharmacokinetic and pharmacodynamic PK/PD study. (Part A)The PK portion of the study is designed to evaluate the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-administration of the two active investigational products, in healthy volunteers and Alzheimer subjects aged 55-79 and in good health. (Part B) The PD portion of the study will evaluate the pharmacodynamics of ALZT- OP1, using both plasma and CSF biomarkers, following 60 days of consecutive daily treatment, in AD subjects only.

Clinical Trial Description

This is a phase I/II randomized, open-label, cross-over, PK/PD study. The PK (Part A) portion of the study is designed to evaluate both single and double doses of ALZT-OP-1a (17.1mg or 34.2 mg) and ALZT-OP1b (10 mg or 20 mg) in both Alzheimer's subjects and healthy volunteers. The PD (Part B) portion of the study is designed to evaluate single doses of ALZT-OP-1a (17.1mg) and ALZT-OP1b (10 mg) in AD subjects treated for 60 days. An Alzheimer's control group will be utilized for comparison to active treatment groups but will not be administered study treatment; however, they will have biomarkers collected.

PK (Part A) n=24, both healthy volunteers and AD subjects

Part A is an open-label study, cross-over, PK study where 24 subjects will be randomly assigned to receive treatment regimen A-B or B-A for two consecutive day of dosing.

Subjects will be admitted to the Phase 1 unit the morning before dosing and will initiate dosing the following morning for 2 consecutive days of dosing (A-B, or B-A).

Day 1 (A-B) will consist of a single inhaled oral dose of ALZT-OP1a via dry powder inhaler + a single oral tablet dose of ALZT-OP1b.

Day 2 (B-A) will consist of two oral inhaled doses of ALZT-OP1a, not more than 2 mins apart, via dry powder inhaler + two oral tablets doses of ALZT-OP1b.

Day 1 (B-A) will consist of two oral inhaled doses of ALZT-OP1a, not more than 2 mins apart, via dry powder inhaler + two oral tablets doses of ALZT-OP1b.

Day 2 (A-B) regimen consists of a single inhaled oral dose of ALZT-OP1a via dry powder inhaler + a single oral tablet dose of ALZT-OP1b.

AD subjects will be given the option to roll over into the PD portion of the study.

PD (Part B) n=32, AD subjects only

Part B is an open-label, PD study where 32 AD subjects will be randomly assigned to receive either active treatment or be assigned to a non-treatment control arm.

Twenty-four (24) subjects will be randomly assigned to Treatment Group 1 to receive a single (17.1 mg) inhaled dose of ALZT-OP1a plus a single (10 mg) oral dose of ALZT-OP1b daily for 60 days.

Eight (8) subjects will be randomly assigned to Treatment Group 2 (Control Group) and will not be administered study drug.

All subjects will have plasma collected on Day 1, Day 30, and Day 60 and CSF collected on Day 1 and Day 60. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Healthy Volunteers

• NCT number: NCT04570644
• Study type: Interventional
• Source: AZTherapies, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: August 28, 2020
• Completion date: January 18, 2021