A randomized double-blind placebo-controlled parallel group study to evaluate the efficacy and safety of CNP520 in participants at risk for the onset of clinical symptoms of Alzheimer's Disease (AD)
Martin Farlow, MD
Primary Investigator
Overview
Description
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Alzheimer's disease
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Age: Between 60 Years - 75 Years
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Gender: All
Inclusion Criteria
Females must be considered post-menopausal and not of child bearing potential or have had surgical bilateral oophorectomy (with or without) hysterectomy), total hysterectomy, or tubal ligation
Intellectually, visually and auditory capable, fluent in, and able to read, the language in which study assessments are administered
Willing to have a study partner throughout the study
Exclusion Criteria
Current medical or neurological condition that might impact cognition or performance on cognitive assessments, e.g., MCI, dementia, Huntington's disease, Parkinson's disease, Lyme disease, syphilis, schizophrenia, bipolar disorder, major depression, active seizure disorder, current alcohol/drug abuse or dependence, or dependence within the last two years or history of head injury with loss of consciousness
Advanced, severe progressive or unstable disease that may interfere with the safety, tolerability and study assessments, or put the participant at special risk, e.g. active hepatitis or HIV infection (based on a positive lab result in the last 12 months for HBV/HCV and/or HIV), severe renal impairment, severe hepatic impairment, uncontrolled or significant cardiac disease including recent (within six months myocardial infarction, congestive heart failure), or unstable angina
History of malignancy of any organ system, treated or untreated, within the past 60 months, regardless of whether there is evidence of local recurrence or metastases. However, localized nonmalignant tumors not requiring systemic chemo- or radio-therapy, localized basal or squamous cell carcinoma of the skin, or in-situ cervical cancer are permitted.
Current treatment with Cholinesterase Inhibitors (ChEIs) and/or another AD treatment
Clinically relevant depigmenting or hypopigmenting conditions (e.g. albinism, vitiligo) or active/history of chronic urticaria in the past year
