Phase II/III Alzheimer’s disease prevention trials of the investigational drugCNP520 for cognitively normal participants
The Generation I and II studies are clinical research studies for individuals ages 60 to 75 with an increased genetic risk of developing clinical symptoms of Alzheimer’s disease.
The Generation I study is for cognitively normal individuals who have two copies of the APOE4 gene. Participants are enrolled through an online registry called the Alzheimer’s Prevention Registry. Interested participants can refer to www.endalznow.org to join the registry.
The Generation II study is for cognitively normal individuals who have one copy of the APOE4 gene. Participants can be enrolled at the Penn Memory Center. Interested participants can contact Clinical Research Coordinator Allison Weiss at 215-615-3133 or email@example.com. In the Generation I and II studies, participants may receive study drug CNP520 or a placebo (a substance with no therapeutic effect). CNP520 is not FDA-approved and is investigational.
Who may be eligible to participate?
Individuals 60-75 years of age who are cognitively normal.
Participants must have a reliable study partner: a spouse, relative, or friend who knows the participant well and sees him or her often, who will attend some study visits, and who will provide information about the participant during the study.
Prior to screening, research participants will meet with a genetic counselor to learn their APOE4 genotype status.
Screening, which may be spaced out over multiple visits, will determine eligibility. It includes:
- a physical/neurological exam
- medical history
- medication review
- electrocardiogram (ECG)
- collection of blood and urine
- tests of memory and thinking
- brain MRI/PET scan
Participants will be asked to attend study visits at the Perelman Center for Advanced Medicine several times per year for 5 to 8 years. Participants will receive the study drug six times in the first year and four times in each year after.
Visits can include cognitive testing, blood work, physical and neurological exams, MRI scans and PET scans.
Participants will be reimbursed for time and travel.
Before enrolling, the participant and study partner must read, understand, and sign an informed consent form, which fully explains the study.
For more information, contact Clinical Research Coordinator Allison Weiss at 215-615-3133 or firstname.lastname@example.org.