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)

Who is this study for? Adults with early-onset Alzheimer's disease
What treatments are being studied? ALN-APP
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Clinical Trial Site
RECRUITING
San Diego
Clinical Trial Site
WITHDRAWN
San Diego
Indiana
Clinical Trial Site
RECRUITING
Indianapolis
Other Locations
Canada
Clinical Trial Site
RECRUITING
Montreal
Clinical Trial Site
RECRUITING
Toronto
Netherlands
Clinical Trial Site
RECRUITING
Amsterdam
United Kingdom
Clinical Trial Site
RECRUITING
London
Clinical Trial Site
RECRUITING
Sheffield
Contact Information
Primary
Alnylam Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-ALNYLAM
Backup
Alnylam Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-256-9526
Time Frame
Start Date: 2022-02-04
Estimated Completion Date: 2029-03-28
Participants
Target number of participants: 60
Treatments
Experimental: Part A: ALN-APP
Participants will be administered a single dose of ALN-APP.
Placebo_comparator: Part A: Placebo
Participants will be administered a single dose of placebo.
Experimental: Part B:
Participants will be administered multiple doses of ALN-APP.
Related Therapeutic Areas
Alzheimer's Disease
Dementia
Sponsors
Leads: Alnylam Pharmaceuticals

This content was sourced from clinicaltrials.gov

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