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CLARITY-1: Efficacy Data

Robust efficacy in restoring sustained detail recognition capacity

CLARITY-1 Study Design

A 24-week, randomised, double-blind, placebo-controlled Phase III trial evaluating DEMOZUMAB in 847 adults with moderate-to-severe Cumulative Detail Fatigue (CDF).

[Study Design Schematic Placeholder]

Key Inclusion Criteria

  • Adults aged 25–65 with confirmed CDF diagnosis
  • Baseline Cognitive Precision Index (CPI) score ≤55
  • History of high-volume sequential assessment tasks (≥6 hours daily)
  • Documented pattern recognition decline over ≥3 months
  • Inadequate response to at least one prior attention management strategy

Primary Endpoint

Proportion of participants achieving Sustained Detail Recognition (SDR-50) at Week 12, defined as ≥50% improvement in error detection rate during standardised assessment tasks.

Primary Endpoint Results

DEMOZUMAB demonstrated statistically significant superiority vs placebo

64%
of patients achieved SDR-50 at Week 12
vs 26% placebo (p<0.001)
[Primary Endpoint Bar Chart Placeholder]

Secondary Endpoints

Endpoint DEMOZUMAB (n=424) Placebo (n=423) p-value
Mean CPI improvement from baseline 47% 12% <0.001
Median increase in time to first missed detail (TTFMD) 3.2 hours 0.4 hours <0.001
SDR-50 response maintained at Week 24 71% 18% <0.001
Patient-reported confidence in accuracy (PRCA) improvement +42 points +8 points <0.001
[Time to First Missed Detail Graph Placeholder]

Efficacy in Chronic CDF (Pre-specified Subgroup)

In patients with CDF duration >5 years (n=312), DEMOZUMAB demonstrated consistent efficacy across key endpoints.

Endpoint DEMOZUMAB (n=156) Placebo (n=156)
SDR-50 at Week 12 58% 21%
Mean CPI improvement 41% 9%
TTFMD increase 2.8 hours 0.3 hours

Patients with chronic CDF reported improved confidence in assessment accuracy and reduced anxiety about missing critical details during extended review sessions.

Durability of Response

Week 12 responders followed through Week 24:

  • 71% of Week 12 responders maintained SDR-50 at Week 24
  • Mean CPI scores remained stable between Weeks 12–24
  • Continued improvement in TTFMD observed through study completion
  • No evidence of efficacy waning over the 24-week treatment period
[Durability of Response Chart Placeholder]

Explore safety & tolerability

DEMOZUMAB was generally well tolerated in CLARITY-1

View safety data →