Together we can light the way for Dementia with Lewy Bodies research.
ABOUT THE SHIMMER STUDY
The SHIMMER study is evaluating the study drug, CT1812, in adults who have been diagnosed with mild to moderate Dementia with Lewy Bodies (DLB).
AM I ELIGIBLE?
WHO IS ELIGIBLE TO PARTICIPATE IN THIS STUDY?
You or a Loved One May Qualify if You or They:
- Are between the ages of 50 to 85
- Have been diagnosed with mild to moderate Dementia with Lewy Bodies (DLB)
- 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 stroke or transient ischemic attack (TIA) within the past 12 months
There are additional study requirements to participate. A SHIMMER study representative will discuss them with you.
ABOUT THE STUDY
The SHIMMER study is evaluating the study drug, CT1812, in adults ages 50 to 85 who have been diagnosed with mild to moderate DLB.
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 oral dose of CT1812. The study will also test how well CT1812 will treat mild to moderate DLB.
Up to 120 participants will be enrolled in the SHIMMER study.
If you take part in the clinical study, your caregiver must accompany you to all your visits, help you with taking the study medication in between visits, and help you report how you are feeling at each visit.
Participants 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*
*A placebo is a capsule that looks identical to the study drug but does not contain any active ingredient. To ensure fairness, neither you nor the study doctor will know whether you or your loved one are receiving CT1812 or placebo.
The total duration of participation in the study is approximately 8 months, including screening. Each participant and caregiver will be required to attend a total of 12 site visits throughout the duration of this study.
Each participant and caregiver will take part in a Screening Visit up to 42 days prior to receiving your first dose, followed by a Double-blind Treatment Period* of 182 days (approximately 6 months) and a Follow-up Visit at Day 210.
*Double-blind Treatment Period is a type of clinical trial in which neither the participants nor the researcher knows which treatment or intervention participants are receiving until the clinical trial is over.
ABOUT THE STUDY DRUG CT1812
Certain proteins (called amyloid beta oligomers and α-synuclein oligomers) are believed to bind to brain cells in patients with DLB, leading to memory problems and confusion. 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 cognitive function or not have the same rate of decline. This type of drug is considered disease-modifying, as it may treat the underlying cause of the condition, not just treat the symptoms.
In early trials, CT1812 was shown to be safe and well tolerated.
WHAT IS DEMENTIA WITH LEWY BODIES (DLB)?
A hallmark of DLB is the accumulation of abnormal protein clumps called Lewy Bodies. Lewy Bodies are primarily composed of α-synuclein fibrils and oligomers. Although the processes by which these protein clumps form and spread through the brain are poorly understood, it is widely thought that the accumulation is linked to synaptic dysfunction, neurodegeneration, and neuronal death.
Symptoms of Lewy Body Dementia include:
- Changes in thinking and reasoning
- Confusion and alertness that varies significantly from one time of day to another or from one day to the next
- Slowness, gait imbalance, and other Parkinsonian movement features
- Well-formed visual hallucinations
- Trouble interpreting visual information
- Sleep disturbances
- Memory loss that may be significant but less prominent than in Alzheimer’s disease
- Changes in body temperature
- Problems with blood pressure
- Frequent falls
- Sensitivity to heat and cold
- Urinary incontinence
- Poor sense of smell
Movement Problems and Lewy Body Dementia:
- Some people with LBD may not experience significant movement problems for several years. Others may experience them early on. At first, movement symptoms, such as a change in handwriting, may be very mild and easily overlooked.
- Movement problems may include:
- Muscle rigidity or stiffness
- Shuffling walk, slow movement, or frozen stance
- Tremor or shaking, most commonly at rest
- Balance problems and repeated falls
- Stooped posture
- Loss of coordination
- Smaller handwriting than was usual for the person
- Reduced facial expression
- Difficulty swallowing
- Weak voice