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

Cognition Therapeutics, Inc., a company focused on developing treatments for neurodegenerative disorders, has shared the baseline characteristics of participants in their Phase 2 'SHIMMER' study concerning mild-to-moderate dementia with Lewy bodies (DLB). The data was presented at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference held in Madrid, Spain. 

Anthony Caggiano, M.D., Ph.D., the Chief Medical Officer and head of R&D at Cognition, explained that the participants showed mild-to-moderate cognitive impairment, with attention fluctuations aligning with a DLB diagnosis. Additionally, most of the participants displayed mild movement impairments. The study comprised 130 participants with a mean age of 72.8 years, of whom 81.5% were male and 91.5% were white. Their mean scores were as follows: Mini-Mental State Examination (MMSE) - 24.0, Montreal Cognitive Assessment (MoCA) - 18.4, Clinician Assessment of Fluctuation (CAF) - 5.9, Epworth Sleepiness Scale (ESS) - 8.4, MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III - 27.7, and Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) - 62.5.

Lisa Ricciardi, the president and CEO of Cognition, highlighted that DLB is a prevalent form of dementia, involving cognitive, motor, psychological, and behavioral impairments that evolve as the disease progresses. She noted that these participant demographics are comparable to other DLB studies, and the company anticipates announcing the results of their study later this year.

The SHIMMER study is a double-blind, placebo-controlled Phase 2 clinical trial, enrolling 130 adults with mild-to-moderate DLB. Participants were equally randomized to receive either a placebo or one of two doses of CT1812 (100 mg or 300 mg) daily for six months. The study employs several assessments, including the MoCA and MMSE for cognitive performance, CAF for cognitive fluctuations, and MDS-UPDRS Part III for parkinsonism.

Supported by a $30 million grant from the National Institute on Aging of the National Institutes of Health (NIH), the SHIMMER study involves collaboration with Dr. James E. Galvin of the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA). Conducted across more than 30 sites in the United States, many of these locations are LBDA centers of excellence.

CT1812, the drug being tested, is an experimental orally administered small molecule that targets the sigma-2 (σ-2) receptor complex and has demonstrated the ability to displace toxic amyloid beta (Aβ) oligomers. The σ-2 receptor complex is crucial in regulating cellular processes like membrane trafficking and autophagy, which can be disrupted by toxic interactions with Aβ oligomers, oxidative stress, and other stressors. This disruption can lead to cognitive impairment and disease progression.

Recruitment is ongoing for other studies involving CT1812, including the START study in adults with early Alzheimer’s disease and the MAGNIFY study in adults with geographic atrophy secondary to dry age-related macular degeneration. The SHIMMER study has completed enrollment for DLB patients.

Cognition Therapeutics, Inc. is dedicated to discovering and developing innovative small molecule therapeutics for age-related degenerative disorders of the central nervous system and retina. Their lead candidate, CT1812, is being investigated in clinical programs for Alzheimer’s disease, DLB, and dry age-related macular degeneration. Targeting the σ-2 receptor with CT1812 offers a unique approach compared to other current treatments in development for degenerative diseases.

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