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 Alzheimers Disease (AD)
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- STATUS
- Recruiting
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- participants needed
- 10
Summary
The study will enroll cognitively unimpaired individuals who are between the ages of 60-75 years with at least one APOE4 allele (HMs or HTs) and, if HTs, with evidence of elevated brain amyloid. Cognitively unimpaired subjects defined as having a Mini-Mental State Examination (MMSE) total score greater than or equal to 24. Subjects must be willing to have a study partner throughout the study. Approximately 2000 participants will be randomized in approximately 135 centers worldwide. The study will be conducted with a randomization ratio 50mg:15mg:placebo of 2:1:2. Arm #1: CNP520 50 mg capsule for. p.o. administrationor CNP520 LDR if DRM is activated Arm #2: CNP520 15 mg capsule for p.o. administrationor CNP520 LDR if DRM is activated Arm #3: Placebo to CNP520 capsules for p.o. administration The investigation drug will be stored in a secured locked cabinet in the Penn Memory Clinic. .
Details
Condition | Alzheimers Disease, ALZ, memory |
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Age | 99years or below |
Clinical Study Identifier | 03131453 |
Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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