NL-OMON54863
Completed
Phase 2
A Randomized, Double-Blind, Placebo Controlled Study of COR388 HCl in Subjects with Alzheimer*s Disease - Study of COR388 in Subjects with Alzheimer's Disease
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Alzheimer's disease
- Sponsor
- Cortexyme, Inc.
- Enrollment
- 31
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject has provided full written informed consent prior to the performance
- •of any protocol\-specified procedure; or if unable to provide informed consent
- •due to cognitive status, subject has provided assent and a legally authorized
- •representative has provided full written informed consent on behalf of the
- •2\. Caregiver has provided full written informed consent, on a separate informed
- •consent form (ICF), on his/her own behalf prior to the performance of any
- •protocol\-specified procedure.
- •3\. Male and female subjects must be 55 years to 80 years of age, at the time of
- •4\. Subject has probable AD dementia according to the NIA\-AA criteria (McKhann
- •2011\) with clinical evidence of progressive cognitive decline in the last year.
Exclusion Criteria
- •Subjects will not be eligible to participate in this study if they meet any of
- •the following exclusion criteria:
- •1\. Subject has imaging consistent with other differential dementia diagnoses
- •other than the diagnosis of AD. For example, any suggestion of vascular disease
- •including multiple infarction involving large blood vessels or localized single
- •infarction (angular gyrus, thalamus, anterior cerebral artery and posterior
- •cerebral artery region), multiple lacunae of the basal nuclei or white matter
- •or extensive lesions of the periventricular white matter or combination of
- •several lesions are considered exclusionary. Additionally, any single lacune
- •in an area known to impact cognition such as the hippocampus will also be
Outcomes
Primary Outcomes
Not specified
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