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Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)

Primary Purpose

Ischemic Stroke, Post-stroke Cognitive Impairment

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Cromolyn

Placebo

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic stroke, post-stroke cognitive impairment, PSCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Male or female, aged 18 years or above;
Subject has suffered a recent (within 1-7 days) ischemic stroke supported by CT scan or MRI findings;
Subject has a score on the NIHSS of 5-14 (inclusive);
Evidence of stroke related cognitive impairment, documented by neuropsychological evaluation and a Clinical Dementia Rating (Global) ≥ 0.5;
Must be fluent in the language of the cognitive testing material being administered;
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;
Visual and auditory acuity adequate for neuropsychological testing.

Exclusion Criteria:

Subject has medical history of dementia (prior to current ischemic stroke event);
Subject has a known medical history of major depression or psychotic disorder;
Unstable cardiovascular or cerebrovascular disease;
Aphasia or other disability severe enough to prevent valid neuropsychiatric assessment;
History of any other significant neurological disease prior to ischemic stroke;
History of schizophrenia or bipolar disorder (DSM-IV criteria);
History of alcohol or substance abuse or dependence within the past 3 years (DSM-IV criteria);
Currently taking medications that could lead to difficulty complying with the protocol;
Investigational agents are prohibited one month prior to entry and for the duration of the trial;
Currently taking cromolyn, or has taken cromolyn, within the past 12 months;
Allergy to cromolyn (also known as Intal®, Nasalcrom®, Opticrom®, Gastrocrom®, etc.);
Clinically significant respiratory disorders with impaired respiratory effort or difficulty taking inhaled drugs (examples: Stage III-IV chronic obstructive pulmonary disease [COPD], emphysema);
Uncontrolled chronic asthma;
Taking inhaled protein products on a chronic basis (such as insulin, parathyroid hormone [PTH], etc.);
Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol;
Pregnancy or lactation for female subjects of child-bearing potential (i.e., < two years post-menopausal or not surgically sterile);
For sexually active male subjects, unwillingness or incapability of using appropriate contraception methods;
Severe renal or hepatic impairment.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ALZT-OP1a

Placebo

Arm Description

ALZT-OP1a: cromolyn (17.1 mg, capsule) for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart.

ALZT-OP1a: placebo capsule for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart.

Outcomes

Primary Outcome Measures

Montreal Cognitive Assessment (MoCA)

The primary endpoint is the difference in performance in the ALZT-OP1a adjuvant treatment group compared to the placebo group, as quantified by the mean change from baseline to Week 12 scored on MoCA.

Secondary Outcome Measures

Mini Mental State Examination (MMSE)

The secondary endpoint is the difference in performance in the ALZT-OP1a adjuvant treatment group compared to the placebo group, as quantified by the mean change from baseline to week 12 in points scored on MMSE.

Full Information

NCT ID

NCT03202147

First Posted

June 26, 2017

Last Updated

February 16, 2022

Sponsor

AZTherapies, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03202147

Brief Title

Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)

Official Title

A Phase II Safety and Efficacy Study of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Study halted prematurely prior to initiation but potentially will resume in the future.

Study Start Date

December 2023 (Anticipated)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AZTherapies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase II, randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI.

Detailed Description

This Phase II study is designed as a randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI. Subjects will be randomly assigned to the Group I arm (ALZT-OP1a adjuvant treatment), which will consist of ALZT-OP1a for inhalation, taken twice daily (morning and evening), OR the Group II placebo arm, which will consist of inhaled placebo, taken twice daily (morning and evening). A minimum of 350 subjects will be randomized to receive one of two possible treatment assignments: ALZT-OP1a adjuvant treatment of active study drug or placebo. To account for subject dropouts (estimated rate of 30%), it is anticipated that up to 500 (or 250 subjects per treatment arm) may be recruited and randomized, to achieve a minimum of 175 evaluable subjects per treatment arm. Randomization assignments will be stratified by site to ensure balance by site.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke, Post-stroke Cognitive Impairment

Keywords

Ischemic stroke, post-stroke cognitive impairment, PSCI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALZT-OP1a

Arm Type

Active Comparator

Arm Description

ALZT-OP1a: cromolyn (17.1 mg, capsule) for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

ALZT-OP1a: placebo capsule for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart.

Intervention Type

Drug

Intervention Name(s)

Cromolyn

Other Intervention Name(s)

Cromolyn sodium

Intervention Description

Active capsules for inhalation.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Non-active capsules for inhalation.

Primary Outcome Measure Information:

Title

Montreal Cognitive Assessment (MoCA)

Description

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

Mini Mental State Examination (MMSE)

Description

Time Frame

Baseline and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Male or female, aged 18 years or above; Subject has suffered a recent (within 1-7 days) ischemic stroke supported by CT scan or MRI findings; Subject has a score on the NIHSS of 5-14 (inclusive); Evidence of stroke related cognitive impairment, documented by neuropsychological evaluation and a Clinical Dementia Rating (Global) ≥ 0.5; Must be fluent in the language of the cognitive testing material being administered; 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; Visual and auditory acuity adequate for neuropsychological testing. Exclusion Criteria: Subject has medical history of dementia (prior to current ischemic stroke event); Subject has a known medical history of major depression or psychotic disorder; Unstable cardiovascular or cerebrovascular disease; Aphasia or other disability severe enough to prevent valid neuropsychiatric assessment; History of any other significant neurological disease prior to ischemic stroke; History of schizophrenia or bipolar disorder (DSM-IV criteria); History of alcohol or substance abuse or dependence within the past 3 years (DSM-IV criteria); Currently taking medications that could lead to difficulty complying with the protocol; Investigational agents are prohibited one month prior to entry and for the duration of the trial; Currently taking cromolyn, or has taken cromolyn, within the past 12 months; Allergy to cromolyn (also known as Intal®, Nasalcrom®, Opticrom®, Gastrocrom®, etc.); Clinically significant respiratory disorders with impaired respiratory effort or difficulty taking inhaled drugs (examples: Stage III-IV chronic obstructive pulmonary disease [COPD], emphysema); Uncontrolled chronic asthma; Taking inhaled protein products on a chronic basis (such as insulin, parathyroid hormone [PTH], etc.); Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol; Pregnancy or lactation for female subjects of child-bearing potential (i.e., < two years post-menopausal or not surgically sterile); For sexually active male subjects, unwillingness or incapability of using appropriate contraception methods; Severe renal or hepatic impairment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David A. Brazier, BS

Organizational Affiliation

AZTherapies, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)

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