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

NCT03202147 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: AZT-003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ischemic Stroke; Post-stroke Cognitive Impairment

Keywords

Ischemic stroke, post-stroke cognitive impairment, PSCI

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12

Secondary Outcomes (1)

• Mini Mental State Examination (MMSE)

  Baseline and Week 12

Study Arms (2)

ALZT-OP1a

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Cromolyn DRUG

Active capsules for inhalation.

Also known as: Cromolyn sodium

ALZT-OP1a

Placebo OTHER

Non-active capsules for inhalation.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• AZTherapies, Inc.: lead

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Cromolyn Sodium

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• David A. Brazier, BS

  AZTherapies, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 3, 2022

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share