Cognition – SHIMMER

Enrolling Now
Study Information

Clinical trial of CT1812 in Mild to Moderate Dementia with Lewy Bodies” = phase 2, randomized, double blind, placebo-controlled 6-month study to evaluate safety, tolerability, and exploratory efficacy of CT1812 in subjects with mild to moderate dementia with Lewy bodies. Across 12 visits, includes numerous cognitive assessments, skin biopsies, optional LPs, and screening MRI.

 

Inclusion Criteria:

  •  Age: 50-85 Inclusive
  • Targets: Probable DLB
  • AD MEDS: No amyloid targeting therapies. AD meds must be stable
  • Clinical Trials: Not within 30 days or 5 half-lives of the investigational drug, whatever is longer
  • Study Partner: Required
  • Mechanism of Action: Inhibits oligomer binding to the sigma-2 receptor complex. Aims to displace both AβO and α-synO from neurons.

Exclusion Criteria:

  • Neurological Disease History: Anything contributing to cognitive impairment beyond the cause of DLB
  • Cancer History: Within 3 years (with exclusions, check w/ SCs)
  • Geriatric Depression Scale: >6
  • HIV, HepB or HepC: N/A
  • C-SSRS: N/A
  • Alcohol or Drug Abuse: Suspected or known abuse at time of screening
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