RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Double-blind, Placebo-controlled Single Ascending Dose and Open-label Multi-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-APP in Adult Patients With Early-onset Alzheimer's Disease (EOAD)

Quick Facts

Study Start:2022-02-04
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05231785

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has mild cognitive impairment or mild dementia due to EOAD
  2. * Has Clinical Dementia Rating (CDR) global score 0.5 or 1.0 and Mini Mental State Examination (MMSE) \>20
  1. * Has Non-Alzheimer's disease dementia
  2. * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2×upper limit of normal (ULN)
  3. * Has estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m\^2 at Screening
  4. * Has recently received an investigational agent
  5. * Has recent treatment with amyloid-targeting antibody

Contacts and Locations

Study Contact

Alnylam Clinical Trial Information Line
CONTACT
1-877-ALNYLAM
clinicaltrials@alnylam.com
Alnylam Clinical Trial Information Line
CONTACT
1-877-256-9526
clinicaltrials@alnylam.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Alnylam Pharmaceuticals

Study Locations (Sites)

Clinical Trial Site
San Diego, California, 92037
United States
Clinical Trial Site
San Diego, California, 92103
United States
Clinical Trial Site
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Alnylam Pharmaceuticals

  • Medical Director, STUDY_DIRECTOR, Alnylam Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-04
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2022-02-04
Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

  • EOAD

Additional Relevant MeSH Terms

  • Early-Onset Alzheimer Disease