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

• Status: Not yet recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AZTherapies, Inc.
• Collaborators: APCER; MedAvante; Pharma Consulting Group (PCG)
• Treatments: Cromolyn Sodium

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.