|

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

RECRUITINGPhase 1Sponsored by Alnylam Pharmaceuticals
Actively Recruiting
PhasePhase 1
SponsorAlnylam Pharmaceuticals
Started2022-02-04
Est. completion2029-04-20
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →

NCT05231785

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

Age: 18 Years+Healthy volunteers accepted
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) \<45 mL/min/1.73m\^2 at Screening
* Has recently received an investigational agent
* Has recent treatment with amyloid-targeting antibody

Note: other protocol defined inclusion / exclusion criteria apply

Conditions2

Alzheimer's DiseaseEarly-Onset Alzheimer Disease

Locations2 sites

California

1 site
Clinical Trial Site
La Jolla, California, 92037

Indiana

1 site
Clinical Trial Site
Indianapolis, Indiana, 46202

Browse More Trials

Alzheimer's Disease trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.