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)
Recruiting
99 years or below
All
Phase
2
10 participants needed
1 Location
Brief description of study
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.
.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Alzheimers Disease, ALZ, memory
-
Age: 99 years or below
-
Gender: All
Updated on
19 Feb 2024.
Study ID: 828295
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