Cognition Therapeutics (CGTX) Study Result summary

Disease background and unmet need

• Dementia with Lewy bodies (DLB) is the second most common cause of dementia after Alzheimer's, affecting 1.4–1.5 million Americans and characterized by fluctuating cognition, neuropsychiatric symptoms, and movement issues.

• DLB is often misdiagnosed, leading to delayed treatment and significant burden for patients and caregivers.

• There are currently no approved disease-modifying therapies for DLB in the US, highlighting a major unmet medical need.

• Current treatments are off-label and only address some symptoms.

Study design and execution

• The SHIMMER (COG-1201) trial was a randomized, double-blind, placebo-controlled phase II study enrolling 130 adults with mild-to-moderate DLB, randomized to receive 100 mg, 300 mg CT-1812, or placebo daily for six months.

• The primary objective was to assess safety and tolerability, with secondary endpoints exploring efficacy across behavioral, cognitive, functional, and motor domains using validated scales.

• The study was supported by a $30 million NIH grant and conducted at over 30 U.S. sites, many affiliated with the Lewy Body Dementia Association.

• The study enrolled 130 patients, with balanced baseline characteristics and most participants on standard-of-care therapies.

• The study was led by Dr. James E. Galvin, a leading expert in DLB research.

Efficacy results

• CT-1812 slowed disease progression by 50–91% across behavioral, cognitive, functional, and motor outcomes compared to placebo.

• Neuropsychiatric symptoms, as measured by the NPI, progressed 82% slower in the CT-1812 group, with notable improvements in anxiety, hallucinations, and delusions.

• Caregiver distress remained stable or improved in the CT-1812 group, a rare outcome in progressive neurodegenerative disease.

• Cognitive decline, including attention fluctuations, daily functioning, and motor symptoms all showed significant slowing of progression in the treatment group.

• Patients treated with CT-1812 showed improvements across behavioral, functional, cognitive, and movement measures compared to placebo.