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WithdrawnPhase 2

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

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

Lead sponsor

AZTherapies, Inc.

Asset

Cromolyn

Listed sites

Recruiting sites

Enrollment

actual

Study population

Vascular cognitive impairment / dementia

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Montreal Cognitive Assessment (MoCA)

Identifiers

Registered as

Org study IDAZT-003

NCT IDNCT03202147

Timeline

Milestones

Study first posted2017-06-28actual

Last update posted2022-03-03actual

Study start2023-12estimated (month precision)

Primary completion2024-12estimated (month precision)

Study completion2024-12estimated (month precision)

Assets

Drug assets

Cromolyn

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

2 endpoints

Primary/protocol endpoint

Montreal Cognitive Assessment (MoCA)

Time frame:Baseline and Week 12

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Secondary/protocol endpoint

Mini Mental State Examination (MMSE)

Time frame:Baseline and Week 12

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.