Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

Conditions

• Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

40 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Praluent (Alirocumab) — DRUG
• Placebo — DRUG

Study Details

The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.

Key Dates

Start date

Nov 2, 2016

Status verified

Apr 2021

Primary completion

Mar 5, 2020

Completion

Mar 5, 2020

Study Design

Enrollment

2,176 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1
  Praluent Regimen - Administration through subcutaneous injection
• Experimental: Group 2
  Placebo matching Praluent - Administration through subcutaneous injection

Primary Outcome Measure

Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96 [ Time Frame: Week 96 ]

Locations (73)

Find similar trials in Auburn, AL

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