The SHINE Study – Multiple Locations


Details

  • Location: Multiple Locations
  • Age: 50 to 85
  • Duration: Approximately 8 months
  • Visits: 13-15
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Eligibility Requirements

You or your loved one may qualify if you or they:

  • Are between the ages of 50 to 85
  • Have been diagnosed with mild to moderate AD
  • Have a caregiver/study partner who is willing and able to attend all study visits and participate in some study assessments
  • Have not had a history of cancer within the last 3 years of screening

There are additional study requirements to participate. A SHINE study representative will discuss them with you.

About the Study:

Certain proteins (called amyloid beta oligomers) are believed to bind to brain cells in patients with Alzheimer’s, leading to memory problems and confusion. The study drug, CT1812, is intended to enter the brain and block these proteins from attaching to brain cells. It is hoped that by blocking these toxic proteins from binding to brain cells, patients with Alzheimer’s will experience improved cognitive function. This type of drug is considered disease-modifying, as it may treat the underlying cause of the condition, not just treat the symptoms.

Purpose:

The purpose of this research study is to learn about the safety of CT1812 and how well you or your loved one tolerate(s) a once-a-day dose of CT1812. The study will also test how well CT1812 will treat mild to moderate Alzheimer’s.

What is Involved:

Subjects will be randomly assigned to 1 of the 3 groups in this study:

Group 1: Will take 100 mg of CT1812 (2 capsules) once daily

Group 2: Will take 300 mg of CT1812 (2 capsules) once daily

Group 3: Will take the placebo (2 capsules) once daily


Participants will be asked to attend 13-15* visits to the study site, plus 2 visits to a local laboratory to have samples of blood taken. Visits will be scheduled approximately every 3 days in the very beginning of the study period (Visits 2 to 4), weekly for 3 weeks (Visits 4 through 7) and then will be scheduled over several weeks as the study continues.

*Participants will be informed which visits are required to attend upon enrollment.

Where it is not possible to visit the study site due to COVID-19, some assessments during Visits 3 to 15, may be performed at home by a certified Home Health Agency.


Participants who take part in the clinical study must be accompanied by a study partner at all study visits, help with taking the study medication in between visits, and help report how the participant is feeling each visit.

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