In April 2024, Cognition Therapeutics announced that enrollment has concluded in the Phase 2 SHIMMER (COG1201) study of CT1812 in adults with mild-to-moderate dementia with Lewy bodies (DLB). Topline results are anticipated in the second half of 2024 after all participants have completed six months of treatment.
About the SHIMMER Study
About the SHIMMER Study
Cognition’s SHIMMER research study is evaluating the study drug, CT1812 in adults who have been diagnosed with mild-to-moderate dementia with Lewy bodies.
About Dementia with Lewy Bodies
Approximately 1.4 million Americans suffer with dementia with Lewy bodies (DLB), making it the second most common cause of neurodegenerative dementia after Alzheimer’s disease.Â
The SHIMMER study is evaluating the investigational study drug, CT1812, for safety and tolerability in adults ages 50 to 85 with mild-to-moderate dementia with Lewy bodies (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 treats mild-to-moderate DLB.
130 participants have been enrolled in the SHIMMER study. Enrollment is now complete.
The study drug, CT1812, is being investigated for the treatment of DLB. CT1812 is a capsule taken every morning by mouth with food. This study drug will be compared to a placebo. A placebo is a capsule that looks identical to the study drug but does not contain any active ingredient. In this research study, participants have a 2 out of 3 chance of receiving the study drug CT1812 versus the placebo.
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. It may treat the underlying cause of the condition, not just treat the symptoms.
In early trials, CT1812 was shown to be generally well tolerated.
Dementia with Lewy bodies (DLB) is one of the most common causes of dementia. DLB, together with Parkinson’s disease dementia (PDD), is a form of Lewy body dementia. Approximately 1.4 million Americans suffer from Lewy body dementia, making it the second most common cause of neurodegenerative dementia after Alzheimer’s disease (AD). In addition to progressive dementia and motor deficits, patients with DLB endure a wide range of debilitating symptoms including cognitive fluctuations, recurrent visual hallucinations, and sleep disorders. DLB patients have a shortened lifespan and rapid cognitive decline compared to AD and PDD patients. As a result, DLB is also associated with greater healthcare costs and caregiver burden than other forms of dementia. Unfortunately, no treatments are available to cure or slow the progression of DLB, making disease-modifying therapies for DLB a critical unmet medical need.
DLB is a complex and challenging neurodegenerative disorder that affects both cognitive and motor functions. Named after the physician Friedrich Lewy, who identified these formations found in the brain, DLB shares similarities with both Alzheimer’s disease and Parkinson’s disease.
- Cognitive Fluctuations: Individuals with DLB often experience unpredictable changes in attention and alertness, leading to variations in cognitive abilities throughout the day.
- Visual Hallucinations: Visual hallucinations are a common feature of DLB. These hallucinations can be vivid and may contribute to the overall challenges faced by individuals and their caregivers.
- Parkinson’s Symptoms: DLB is associated with motor symptoms similar to Parkinson’s disease, including tremors, stiffness, and a shuffling walk. These symptoms can impact daily activities and mobility.
- REM Sleep Behavior Disorder (RBD): Many individuals with DLB experience RBD, a condition where normal paralysis during the REM (rapid eye movement) stage of sleep is absent, leading to physically acting out dreams.
- Fluctuating Alertness and Attention: Individuals with DLB may exhibit episodes of confusion, disorientation, and impaired attention, which can fluctuate in severity.
- 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
- Delusions
- 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
- Dizziness
- Fainting
- Frequent falls
- Sensitivity to heat and cold
- Urinary incontinence
- Constipation
- Poor sense of smell
- 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
For more information about the SHIMMER study, please visit clinicaltrials.gov and reference study ID NCT05225415.