Cognition Therapeutics Shares Phase 2 Dementia with Lewy Bodies Study Demographics at CTAD

Cognition Therapeutics, Inc., a company focused on developing drugs for neurodegenerative disorders, showcased the initial participant characteristics in their Phase 2 'SHIMMER' study targeting mild-to-moderate dementia with Lewy bodies (DLB). This data was presented at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid.

Anthony Caggiano, M.D., Ph.D., the company's Chief Medical Officer, highlighted that the study participants exhibited mild-to-moderate levels of cognitive impairment with consistent attention fluctuations, supporting their clinical DLB diagnosis. The majority also displayed mild motor impairments.

Lisa Ricciardi, the President and CEO of Cognition, emphasized that DLB is a prevalent form of dementia characterized by diverse symptoms such as cognitive, motor, psychological, and behavioral changes. She noted that these participant characteristics align with previous DLB studies and expressed anticipation for the study results expected later in the year.

Dementia with Lewy bodies is the second most common form of dementia, affecting approximately 1.4 million Americans. It involves the accumulation of the protein α-synuclein in brain neurons, leading to disruptions in autonomic, digestive, cognitive, and motor systems. Symptoms can include fluctuating alertness, hallucinations, delusions, movement disorders, and REM sleep disorder. Currently, only a limited number of symptomatic treatments exist, with no disease-modifying therapies available.

The SHIMMER study is a double-blind, placebo-controlled Phase 2 clinical trial involving 130 adults with mild-to-moderate DLB. Participants were randomly assigned to receive either a placebo or one of two oral doses of CT1812 (100 mg or 300 mg) daily for six months. The study employs various assessment tools including the Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), Clinician Assessment of Fluctuation (CAF), and the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III to evaluate cognitive performance and parkinsonism.

This study is supported by a grant from the National Institute on Aging, amounting to approximately $30 million. It is conducted in collaboration with Dr. James E. Galvin from the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA). The study spans over 30 sites in the United States, many of which are LBDA centers of excellence.

CT1812, the drug being tested, is an experimental small molecule that can penetrate the blood-brain barrier and selectively binds to the sigma-2 (σ-2) receptor complex. Preclinical and clinical data suggest that this binding displaces toxic Aβ oligomers, which are implicated in damaging synapses and contributing to cognitive impairment and Alzheimer’s disease progression.

Cognition Therapeutics is also recruiting participants for other studies involving CT1812. These include the START study for early Alzheimer’s disease and the MAGNIFY study for adults with geographic atrophy secondary to dry age-related macular degeneration. Enrollment has concluded for the SHIMMER study in individuals with dementia with Lewy bodies.

Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company, focusing on discovering and developing innovative small molecule therapeutics for age-related degenerative disorders of the central nervous system and retina. Their lead candidate, CT1812, is under investigation for potential effectiveness in treating Alzheimer’s disease, dementia with Lewy bodies, and dry age-related macular degeneration. They believe targeting the σ-2 receptor with CT1812 offers a unique mechanism distinct from other current treatment approaches for degenerative diseases.