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

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ClinicalTrials.gov Identifier: NCT03202147
Recruitment Status : Suspended (Study halted prematurely prior to initiation but potentially will resume)
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborators:
MedAvante
Pharma Consulting Group (PCG)
APCER
Information provided by (Responsible Party):
AZTherapies, Inc.

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

Condition or disease Intervention/treatment Phase
Ischemic Stroke Post-stroke Cognitive Impairment Drug: Cromolyn Other: Placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2016
Estimated Primary Completion Date : August 2017
Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ALZT-OP1a
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.
Drug: Cromolyn
Active capsules for inhalation.
Other Name: Cromolyn sodium

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




Primary Outcome Measures :
  1. Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline and Week 12 ]
    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 :
  1. Mini Mental State Examination (MMSE) [ Time Frame: Baseline and Week 12 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202147


Sponsors and Collaborators
AZTherapies, Inc.
MedAvante
Pharma Consulting Group (PCG)
APCER
Investigators
Study Chair: David R. Elmaleh, PhD AZTherapies, Inc.
Study Director: David A. Brazier, BS AZTherapies, Inc.

Responsible Party: AZTherapies, Inc.
ClinicalTrials.gov Identifier: NCT03202147     History of Changes
Other Study ID Numbers: AZT-003
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by AZTherapies, Inc.:
Ischemic stroke, post-stroke cognitive impairment, PSCI

Additional relevant MeSH terms:
Stroke
Ischemia
Cognitive Dysfunction
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Brain Infarction
Brain Ischemia
Cromolyn Sodium
Anti-Asthmatic Agents
Respiratory System Agents