trialsTrialCompleted

CLARITY AD

CLARITY AD tested lecanemab in early Alzheimer’s disease. It is the main efficacy trial behind the US traditional approval.

A randomised, placebo-controlled phase 3 study in early symptomatic Alzheimer’s disease with confirmed amyloid. Primary clinical scale results favoured lecanemab. ARIA occurred, more often in ApoE ε4 carriers. This atlas does not treat a mean scale change as a promise for an individual.

Setting

Early Alzheimer’s disease

Phase

Phase 3

Sponsor

Eisai

Registry

NCT03887455

Headline result

The trial met its primary clinical endpoint versus placebo. ARIA was the principal safety theme. See the FDA approval communication for the regulator’s reading.

Reported

2023

Enrolled

1795

Outcomes

1top

In plain words

What these results mean for people, not percentages

1,795 people took part

Clinical scale change (primary)primaryother endpoint

Numbers are not recorded here for this endpoint. Lecanemab: Favoured versus placebo on the primary scale; Placebo.

This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
These results apply to the people the trial enrolled: Early Alzheimer’s disease. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

1,795 participants enrolled.

Clinical scale change (primary)primary

Favoured versus placebo on the primary scale

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Clinical scale change (primary)primary	Lecanemab	-	Favoured versus placebo on the primary scale	-	-	link
Clinical scale change (primary)primary	Placebo	-	-	-	-	link