Gantenerumab for Alzheimer's Disease (DIAN-TU Trial)

Phase 2 & 3

Recruiting

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up stage 2 week 208

Summary

This trial will study if treatment with an investigational study drug can prevent or slow the rate of Alzheimer's disease (AD)-causing accumulation of amyloid beta (Aβ). Part 1 will use Aβ positron emission tomography (PET) imaging to determine if treatment with the study drug prevents or slows the rate of Aβ pathological disease accumulation. Part 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD.

Who is the study for?

This trial is for adults over 18 with a genetic mutation linked to early onset Alzheimer's Disease (AD), or those with a 50% chance of having the mutation. Participants must be within certain years of expected symptom onset, have normal cognitive function, and agree to use contraception if applicable. Those already on stable medication can join, except for certain episodic treatments.

What is being tested?

The study tests Gantenerumab against a placebo in preventing or slowing amyloid beta accumulation in the brain, as seen by PET imaging. It also examines whether reducing amyloid plaques early affects AD progression by comparing biomarkers with an external control group.

What are the potential side effects?

While specific side effects are not listed here, typically such trials monitor for drug safety and tolerability which may include reactions at injection sites, potential allergic responses, general discomforts like headaches or nausea, and other drug-specific adverse effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ stage 2 week 208

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~stage 2 week 208

This trial's timeline: 3 weeks for screening, Varies for treatment, and stage 2 week 208 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stage 1: Evaluate the ability of study drug to prevent or slow the rate of Aβ accumulation compared with placebo in participants with mutations that cause DIAD

Stage 2: Evaluate the effect of anti-amyloid treatment on downstream biomarkers of AD