Cognition Therapeutics, Inc. · NASDAQ:CGTX
Cognition Therapeutics — International Lewy Body Dementia Conference 2025
28 slides from Cognition Therapeutics's conference presentation, Jan 31, 2025
Slide 1: Phase 2 Study of CT1812 in Mild-to-Moderate Dementia with Lewy Bodies: Topline Results
Phase 2 Study of CT1812 in Mild-to-Moderate Dementia with Lewy Bodies: Topline Results International Lewy Body Dementia Conference 2025 Amsterdam, The Netherlands 31 January 2025 James E. Galvin, MD, MPH Director of the Comprehensive Center for Brain Health University of Miami Miller School of Medic
Slide 2: Disclosures
Disclosures Presenter Disclosures: • Grants from the National Institutes of Health • Consultant for Alpha Cognition, Biogen, Bristol Meyers Squibb, DiagnaMed, Eisai, Eli Lilly, GE Healthcare, Genentech, Lundbeck, Roche, and Thema Medical • Chief Scientific Officer for Cognivue, Inc • Clinical trial
Slide 3: Four Symptom Domains Drive Lewy Body Disease Burden
Four Symptom Domains Drive Lewy Body Disease Burden “A multifactorial disease with a buffet of symptoms” Behavior Cognition Function Movement Patient Hallucinations, Memory and Bathing, toileting, shopping, Standing, symptom anxiety, delusions problem solving meal preparation maintaining balance M
Slide 4: SHIMMER Study Designed to Assess Multifactorial Burden
SHIMMER Study Designed to Assess Multifactorial Burden Conducted in Collaboration with LBDA Centers of Excellence, Academic Centers and Industry Partially funded by NIA (R01AG071643) Treatment Period Assessments Study Objectives 6 months 130 participants randomized from 31 sites across U.S. Safety/t
Slide 5: Patient Characteristics Consistent with Typical DLB Population
Patient Characteristics Consistent with Typical DLB Population Well balanced between treatment and placebo arms 100mg CT1812 300mg CT1812 Placebo Total (n=44) (n=44) (n=42) (n=130) Age – years* 72.6 (7.82) 72.1 (5.90) 73.7 (6.25) 72.8 (6.69) Gender: % Male 79.5 86.4 78.6 81.5 Race: % White 95.5 8
Slide 6: Participant Disposition
Participant Disposition 293 Screened 130 Randomized 44 Randomized 44 Randomized 42 Randomized to 100mg CT1812 to 300mg CT1812 to placebo 40 Completed 33 Completed 11 Discontinued Tx 36 Completed 8 Discontinued Tx 4 Discontinued Tx 9 (20.5%) DC due to AE 5 (11.9%) DC due to AE study 4 (9.1%) DC
Slide 7: CT1812 Showed 86% Impact on Neuropsychiatric Measures
CT1812 Showed 86% Impact on Neuropsychiatric Measures NPI captures a variety of patient disturbances, including hallucinations, anxiety, and delusions NPI Total Score (A-L) NPI Favors Treatment with CT1812 LS Mean (SE) Difference from Placebo (95% CI) 7 NPI: Neuropsychiatric inventory
Slide 8: CT1812 Showed 86% Impact on Neuropsychiatric Measures
CT1812 Showed 86% Impact on Neuropsychiatric Measures NPI captures a variety of patient disturbances, including hallucinations, anxiety, and delusions NPI Total Score (A-L) NPI Favors Treatment with CT1812 LS Mean (SE) Difference from Placebo (95% CI) 8 NPI: Neuropsychiatric inventory
Slide 9: CT1812 Reduced Caregiver Distress
CT1812 Reduced Caregiver Distress ‘NPI Distress’ measures levels of care partner distress in DLB (p=0.025) NPI A-L Distress: Caregiver Distress NPI Distress Favors Treatment with CT1812 LS Mean (SE) Difference from Placebo (95% CI) 9
Slide 10: CT1812 Reduced Caregiver Distress
CT1812 Reduced Caregiver Distress ‘NPI Distress’ measures levels of care partner distress in DLB (p=0.025) NPI A-L Distress: Caregiver Distress NPI Distress Favors Treatment with CT1812 LS Mean (SE) Difference from Placebo (95% CI) 10 NPI Distress: Neuropsychiatric inventory (Care Partner Distress)
Slide 11: CDR Memory-related Item Scores Reflect Improvements in Factors Important in DLB
CDR Memory-related Item Scores Reflect Improvements in Factors Identified as Important in Patients with DLB* Improved memory accuracy for word recall, picture recognition and working memory Pooled CT1812 (100mg + 300mg) vs. Placebo (ITT) Percent Slowing for 5 Composites Relative to Placebo (95% CI)
Slide 12: Up to 85% Slowing of Decline Across CDR Domains
Up to 85% Slowing of Decline Across CDR Domains CT1812 improved patients’ attentiveness and problem solving CDR – Quality of Episodic 2° Memory (ITT) CDR – Quality of Working Memory (ITT) CDR – Quality of Memory (ITT) 12 CDR: Cognitive Drug Research System
Slide 13: Up to 85% Slowing of Decline Across CDR Domains
Up to 85% Slowing of Decline Across CDR Domains CT1812 improved patients’ attentiveness and problem solving CDR – Quality of Episodic 2° Memory (ITT) CDR – Quality of Working Memory (ITT) CDR – Quality of Memory (ITT) 13 CDR: Cognitive Drug Research System
Slide 14: Fewer Fluctuations with CT1812
Fewer Fluctuations with CT1812 91% reduction of cognitive fluctuations (CAF) Clinicians Assessment of Fluctuations (CAF) Fluctuations Inconsistent Reduced responsiveness Variable attention Altered consciousness 14
Slide 15: Fewer Fluctuations with CT1812
Fewer Fluctuations with CT1812 91% reduction of cognitive fluctuations (CAF) Clinicians Assessment of Fluctuations (CAF) Fluctuations Inconsistent Reduced responsiveness Variable attention Altered consciousness 15
Slide 16: People on CT1812 Maintained ADLs
People on CT1812 Maintained ADLs 52% preservation in activities of daily living (ADL) with p=0.05 ADCS - Activities of Daily Living (ADL) Components of ADL Score Bathing Toileting Dressing Conversing Grooming Shopping Feeding Writing 16
Slide 17: People on CT1812 Maintained ADLs
People on CT1812 Maintained ADLs 52% preservation in activities of daily living (ADL) with p=0.05 ADCS - Activities of Daily Living (ADL) Components of ADL Score Bathing Toileting Dressing Conversing Grooming Shopping Feeding Writing 17
Slide 18: People on CT1812 Maintained Motor Function
People on CT1812 Maintained Motor Function 62% preservation in measures of movement MDS-UPDRS (Part 3) Components of UPDRS: Balance Gait Speech Facial expression Rigidity Tremor 18 MDS-UPDRS: MDS-Unified Parkinson's Disease Rating Scale (Part III)
Slide 19: People on CT1812 Maintained Motor Function
People on CT1812 Maintained Motor Function 62% preservation in measures of movement MDS-UPDRS (Part 3) Components of UPDRS: Balance Gait Speech Facial expression Rigidity Tremor 19 MDS-UPDRS: MDS-Unified Parkinson's Disease Rating Scale (Part III)
Slide 20: Minimal Changes Observed in MoCA or ESS
Minimal Changes Observed in MoCA or ESS Montreal Cognitive Assessment (MoCA) Epworth Sleep Scale (ESS) Only one participant reported lethargy (105-0001) 20
Slide 21: Minimal Changes Observed in MoCA or ESS
Minimal Changes Observed in MoCA or ESS Montreal Cognitive Assessment (MoCA) Epworth Sleep Scale (ESS) One participant reported mild, transient lethargy 21
Slide 22: Percent Slowing at Day 182 for Exploratory Efficacy Endpoints of Interest
Percent Slowing at Day 182 for Exploratory Efficacy Endpoints of Interest Pooled CT1812 100mg +300 mg vs. Placebo ITT Population 22 Note: The 95% CI for ESS is (-1050, 400) which is too wide to present in this plot alongside the other efficacy endpoints.
Slide 23: Biomarkers
Biomarkers No significant treatment differences were observed Biomarkers: • Change from baseline levels in plasma were assessed for known markers of neuroinflammation and disease biology • Change from baseline in phosphorylated alpha-synuclein 129 ❖ Aβ monomers (1-40, 1-42) & ratio via skin biopsy w
Slide 24: COG1201 (SHIMMER): Safety Summary
CT1812 Placebo Total Subjects with: 100 mg 300 mg (N=42) (N=129) (N=44) (N=43) At least one TEAE 42 (95.5%) 40 (93.0%) 37 (88.1%) 119 (92.2%) At least one TEAE related to treatment 14 (31.8%) 21 (48.8%) 16 (38.1%) 51 (39.5%) At least one TEAE leading to discontinuation of 4 (9.1%) 9 (20.9%) 5 (11.9%
Slide 25: Most Common Treatment-Emergent Adverse Events (TEAEs)
CT1812 Placebo Total Preferred Term n (%) 100 mg 300 mg (N=42) (N=129) (N=44) (N=43) Fall 7 (15.9%) 14 (32.6%) 10 (23.8%) 31 (24.0%) Headache 4 (9.1%) 7 (16.3%) 8 (19.0%) 19 (14.7%) Lipase increase 5 (11.4%) 7 (16.3%) 6 (14.3%) 18 (14.0%) Most Common Urinary tract infection 3 (6.8%) 3 (7.0%) 8 (19.0
Slide 26: Summary of SHIMMER Safety and Tolerability findings
Summary of SHIMMER Safety and Tolerability findings Favorable safety profile vs placebo, AEs well balanced between arms Total AE frequency was similar There were no deaths related Participants with LFT elevations in CT1812 and placebo to study drug ≥ 3x ULN • 100mg CT1812 – 3 • 300mg CT1812 –
Slide 27: Strong Early Data Supporting CT1812 for DLB
Strong Early Data Supporting CT1812 for DLB Safety and efficacy to be confirmed in phase 3 trials • SHIMMER suggests CT1812 can slow progression in DLB • Evidence across multiple endpoints • Safe and well tolerated* Behavior Cognition Function Movement • Results support advancement of CT1812 into la
Slide 28: Acknowledgements
Acknowledgements Cognition Therapeutics is grateful to everyone involved in the COG1201 SHIMMER Trial Most importantly – each study participant and their care partners University of Miami and Dr. James Galvin Our collaborators at the Lewy Body Dementia Association and their Centers of Excellence Sit
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