Dementia with Lewy bodies (DLB) is one of the most common causes of dementia. It is the second most common type of dementia diagnosed in older adults after Alzheimer’s disease (AD). In addition to worsening dementia and motor deficiency, patients with DLB endure a wide range of symptoms including cognitive fluctuations, recurrent visual hallucinations, and sleep disorders. Unfortunately, no treatments are available to cure or slow the progression of DLB.
This Phase 2 research study is designed to evaluate the safety and effectiveness of a study drug called CT1812, in adults between the ages of 50-85 who have been diagnosed with mild to moderate Dementia with Lewy Bodies disease (DLB). The purpose of this 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 DLB. Certain proteins (called amyloid beta oligomers and α-synuclein oligomers) are believed to bind to brain cells in patients with DLB. 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 DLB will experience improved symptoms.
This research study is a randomized double-blind, controlled clinical study, which means that you/ participant will randomly be assigned to one of three potential groups by chance, like the flip of a coin. You/participant will have a 66.6% chance of receiving the study drug versus a 33.4% chance of receiving a placebo.
Participants will be randomly assigned to one of these three groups:
- Group 1: 100 mg of CT1812 (2 capsules) once daily
- Group 2: 300 mg of CT1812 (2 capsules) once daily
- Group 3: Placebo (2 capsules) once daily
If you agree to take part in this research study, participants and caregivers will receive $100 and $75, respectively for each study visit made during the screening process. In addition, to help cover expenses, the study will pay for any services, supplies, procedures, or care related to the study that are not routine medical care.
- ClinicalTrials.gov: NCT05225415
Contact JWM Neurology
For more information, contact the JWM Neurology Research Department at 317-537-6056 for more information.