For additional information, call Anne at IPC Research, 262-955-6515.
SUVN-502 works on a different chemical messaging pathway within the brain than the standard treatments for Alzheimer's disease.
All participants will also continue to take their existing Alzheimer's treatment throughout the entire 30 weeks, which will be:
Participants can leave the study at any time for any reason. A decision to leave the study, or a decision not to take part, will not affect the standard of care provided to the participant outside of the study.
Study-related care and study medications (with the exception of Namenda XR® and Namzaric™) will be provided at no charge.
There are 3 treatment groups:
a replacement will need to be found for the participant to remain in the study.
The purpose of the SUVN-502 Study is to see whether an investigational* medication - known as SUVN-502 - has an effect on the symptoms of Alzheimer's disease when given along with the standard treatments, donepezil and memantine.
Participants will need a friend or relative who would be willing to be their study partner throughout the study. This needs to be someone who:
All study medication will be 1 tablet, to be taken once every day for the 26-week treatment period.
Participants and their study partners will attend 5 clinic visits over the 26-week treatment phase. During these visits, the study team will check on the participant's symptoms and overall health using standard medical tests, questionnaires, and interviews.
Anyone with Alzheimer's disease who wishes to join the SUVN-502 Study will be assessed by the study doctor first. This will involve medical tests and examinations to find out if they are right for the study, and if the study is right for them. Once enrolled in the study, participation is expected to last about 30 weeks (7 months).
The SUVN-502 Study will involve approximately 530 people with Alzheimer's disease across 90
Participants will be randomly placed (like the flip of a coin) into one of these 3 treatment groups. The participant, study partner and study doctor and his/her staff will not know which group the participant is in.
*'Investigational' means that the medication is not approved for use outside of a clinical research study.
Donepezil 10 mg once daily, plus
Memantine 10 mg twice daily / Namenda XR® 28 mg once daily / or as part of combination therapy Namzaric™ (28 mg memantine HCI/10 mg donepezil HCI qd).
study centers in the USA.
Is in regular contact with the participant (at least 12 hours per week across 3 to 5 days)
Is willing to provide feedback on the participant's symptoms and well-being
Is willing to assist the participant with taking all study medications
Is willing to accompany the participant to all clinic visits.
Lower-dose investigational study drug
Higher-dose investigational study drug
Placebo (this is a tablet that contains no investigational study drug).
If the study partner leaves the study,