This is a Phase 1 clinical trial sponsored by Lilly, designed for individuals with mild cognitive impairment or mild Alzheimer’s disease. The study involves an investigational drug administered via injection into the spinal column, and aims to evaluate whether the treatment can reduce levels of tau protein.

About

Patient Population: Early Alzheimer’s Disease

Study Drug: LY3954068 (Anti-Tau siRNA)

Single intrathecal injections, 5LPs; minimum 2-night stay in DEPRU

Inclusion Criteria

• Age 50 – 85
• MMSE 18 – 30
• BMI 18 – 40
• Medical co-morbidities must be stable with no medication changes within the past 3 months.

Confirmation of amyloid pathology not required. If amyloid PET or CSF testing available, this well expedite screening. Otherwise participant will have blood pTau testing.

Exclusion Criteria

• Anti-amyloid therapy exposure within the past year
• Significant lumbar pathology that would interfere with LPs
• More than 2 areas of superficial siderosis; more than 5 micro hemorrhages; or prior history of macro hemorrhage
• Systemic anticoagulants or antithrombotics (low dose ASA is allowed)
• Significant renal impairment (eGFR <45)
• Platelet count <100,000