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Recruiting NCT05231785

A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD

Conditions: Early-Onset Alzheimer Disease

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE1

Enrollment: 60

Sponsor: Alnylam Pharmaceuticals

Location: Clinical Trial Site La Jolla California

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose and multiple doses of ALN-APP administered by intrathecal (IT) injection in adult patients with early-onset Alzheimer's Disease (EOAD). Maximum treatment duration for Part A: single dose. Maximum treatment duration for Part B: 12 months.

Eligibility Criteria

Inclusion Criteria: * Has mild cognitive impairment or mild dementia due to EOAD * Has Clinical Dementia Rating (CDR) global score 0.5 or 1.0 and Mini Mental State Examination (MMSE) \>20 Exclusion Criteria: * Has Non-Alzheimer's disease dementia * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2×upper limit of normal (ULN) * Has estimated glomerular filtration rate (eGFR) \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05231785). StuddyBuddy aggregates publicly available trial information.