Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cogn… (NCT03202147) | Clinical Trial Compass
WithdrawnPhase 2
Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)
Stopped: Study halted prematurely prior to initiation but potentially will resume in the future.
0Started 2023-12
Plain-language summary
This is a Phase II, randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
*…