A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy

Part of paid clinical trials in Los Angeles, California.

Sponsor
Alnylam Pharmaceuticals
Study ID
NCT06393712
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cerebral Amyloid Angiopathy

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo will be administered intrathecally
  • ALN-APP — DRUG
    ALN-APP will be administered intrathecally

Study Details

The purpose of the study is to evaluate the effect of ALN-APP on measures of CAA disease progression and to characterize the safety, tolerability, and pharmacodynamics (PD) of ALN-APP in adult patients with sporadic CAA (sCAA) and Dutch-type CAA (D-CAA). The study will be conducted over 2 periods: a 24-month double-blind treatment period and an optional 18-month open-label extension (OLE) period. The estimated duration of study participation, inclusive of screening, treatment, and additional safety follow-up, is up to 50 months.

Key Dates

Start date
May 17, 2024
Status verified
May 2026
Primary completion
Aug 9, 2027
Completion
Dec 14, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ALN-APP
    Participants will be administered multiple doses of ALN-APP during the double-blind treatment period and optional open-label extension period.
  • Placebo Comparator: Placebo/ALN-APP
    Participants will be administered multiple doses of placebo during the double-blind treatment period. Participants who continue into the optional open-label extension period will be administered multiple doses of ALN-APP.

Primary Outcome Measure

Double-blind Treatment Period: Annualized Rate of New Lobar Cerebral Microbleeds (CMBs) Assessed on Magnetic Resonance Imaging (MRI) of Brain in Patients with Sporadic Cerebral Amyloid Angiopathy (sCAA) [ Time Frame: Up to 24 months ]

Central Contacts

Locations (34)

FacilityCityStateZIPSite coordinators
Clinical Trial SiteLos AngelesCalifornia90095-
Clinical Trial SiteOrangeCalifornia92868-
Clinical Trial SitePalo AltoCalifornia94304-
Clinical Trial SiteSacramentoCalifornia95816-
Clinical Trial SiteSan FranciscoCalifornia94114-
Clinical Trial SiteAuroraColorado80045-
Clinical Trial SiteNew HavenConnecticut06510-
Clinical Trial SiteGainesvilleFlorida32608-
Clinical Trial SiteJacksonvilleFlorida32224-
Clinical Trial SiteMaitlandFlorida32751-
Clinical Trial SiteNaplesFlorida34105-
Clinical Trial SiteChicagoIllinois60612-
Clinical Trial SiteLexingtonKentucky40504-
Clinical Trial SiteNew OrleansLouisiana70121-
Clinical Trial SiteBostonMassachusetts02114-
Clinical Trial SitePlymouthMassachusetts02360-
Clinical Trial SiteRochesterMinnesota55905-
Clinical Trial SiteSt LouisMissouri63110-
Clinical Trial SiteHackensackNew Jersey07601-
Clinical Trial SiteNew YorkNew York10016-
Clinical Trial SiteNew YorkNew York10029-
Clinical Trial SiteNew YorkNew York10032-
Clinical Trial SiteNew YorkNew York10065-
Clinical Trial SiteDurhamNorth Carolina27705-
Clinical Trial SiteCantonOhio44718-
Clinical Trial SiteClevelandOhio44195-
Clinical Trial SiteAbingtonPennsylvania19001-
Clinical Trial SitePhiladelphiaPennsylvania19104-
Clinical Trial SitePittsburghPennsylvania15213-
Clinical Trial SiteDallasTexas75243-
Clinical Trial SiteDallasTexas75390-
Clinical Trial SiteHoustonTexas77030-
Clinical Trial SiteSan AntonioTexas78229-
Clinical Trial SiteSeattleWashington98104-

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