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Anti-amyloid agent

ION269 for Down Syndrome at Risk of Alzheimer's Disease

Phase 1
Recruiting
Research Sponsored by Ionis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test if ION269 is safe and well-tolerated in adults with Down syndrome who show signs of brain amyloid buildup.

Who is the study for?
This trial is for adults with Down syndrome who are at risk for Alzheimer's. They need a reliable caregiver, an IQ of 45 or higher, evidence of brain amyloid on PET scans, and stable cognition without dementia or mild cognitive impairment.
What is being tested?
ION269 is being tested to see if it's safe and tolerable for those with Down syndrome showing signs that may lead to Alzheimer's. The study looks into how the body processes the drug and its effects on the body.
What are the potential side effects?
The trial aims to identify side effects of ION269; however, specific side effects aren't listed here. Generally, such trials monitor for any adverse reactions ranging from mild discomforts like headaches to more serious conditions.

Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Participants will receive a single dose of ION269.
Group II: Cohort 2Experimental Treatment1 Intervention
Participants will receive a single dose of ION269.
Group III: Cohort 1Experimental Treatment1 Intervention
Participants will receive a single dose of ION269.

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Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor
150 Previous Clinical Trials
27,732 Total Patients Enrolled
~20 spots leftby Feb 2027
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