ALN-APP for Cerebral Amyloid Angiopathy (cAPPricorn-1 Trial)

Phase 2

Recruiting

Research Sponsored by Alnylam Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is 50 years or older

Is 30 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial aims to test how well ALN-APP works in slowing down the progression of CAA disease in adults with sCAA and D-CAA. The study will include a 24-month period

Who is the study for?

This trial is for adults aged 50 or older with probable Cerebral Amyloid Angiopathy (CAA) as per Boston Criteria, or those 30 and above with a known E693Q amyloid precursor protein gene mutation linked to Dutch-type CAA. It's not suitable for individuals who don't meet these specific conditions.

What is being tested?

The study tests the effects of ALN-APP on slowing down CAA disease progression compared to a placebo. Participants will be randomly assigned to receive either ALN-APP or placebo over a period of up to 50 months, including an optional extension phase.

What are the potential side effects?

While the side effects are not explicitly listed here, common issues in trials like this may include injection site reactions, flu-like symptoms, headache, nausea, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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I am 30 years old or older.

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I have a specific genetic mutation known as E693Q.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ALN-APPExperimental Treatment1 Intervention

Participants will be administered multiple doses of ALN-APP during the double-blind treatment period and optional open-label extension period.

Group II: Placebo/ALN-APPPlacebo Group2 Interventions

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.

0 / 3Eligibility criteria met