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Clinical Trial ● Currently Recruiting Phase I NCT05231785

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

A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD — Recruiting • Phase I • Neurology • NCT05231785.

📅 31 Mar 2026 ⏱ 1 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase I
NCT ID
NCT05231785
Sponsor
Alnylam Pharmaceuticals
Start
2022-02-04
ClinicaliQ Trial Snapshot
  • A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD — Recruiting • Phase I • Neurology • NCT05231785.
  • 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….
  • Sponsor: Alnylam Pharmaceuticals.

Verify eligibility, endpoints and current status on the original source registry before acting on this summary.

Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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 Snapshot
  • : * 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

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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