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Nicotine patch for Cognitive Impairment

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

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 day 1 or day 8

Summary

This trial uses nicotine patches and MK-4334 capsules to study their effects on brain activity in people with mild-to-moderate schizophrenia. The goal is to see if these treatments can help improve brain function in those with schizophrenia. Nicotine has been found to improve cognitive functions in schizophrenia, such as attention and memory.

Eligible Conditions

Cognitive Impairment

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 or day 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 or day 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 or day 8 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean inter-trial coherence (ITC) magnitude of 40 Hz-derived auditory steady-state response (ASSR) in HC and SZ participants

Secondary study objectives

Duration deviant mismatch negativity (DD-MMN) in HC and SZ participants

Effect of nicotine on mean ITC magnitude of 40 Hz-derived ASSR in HC and SZ participants

Plasma nicotine level during event related potential (ERP) recording

Side effects data

From 2020 Phase 4 trial • 1251 Patients • NCT03176784

31%

Nausea

27%

Insomnia

16%

Changes in Mood

10%

Skin Rash

Headache

Itching/Hives

100%

80%

60%

40%

20%

Study treatment Arm

Varenicline Only Extended Duration

Varenicline + Patch Standard Duration

Varenicline Only Standard Duration

Varenicline + Patch Extended Duration

Trial Design

2Treatment groups

Experimental Treatment

Group I: Panel B: Participants with Mild-to-Moderate SZExperimental Treatment4 Interventions

In Part 1, participants with mild-to-moderate SZ receive nicotine patch + capsule placebo, and patch placebo + capsule placebo, under a cross-over design in Periods 1 and 2. In Part 2 (Period 3), SZ participants are randomly assigned to receive either MK-4334 250 mg capsule + patch placebo or capsule placebo + patch placebo.

Group II: Panel A: Healthy Control ParticipantsExperimental Treatment4 Interventions

In Part 1, HC participants receive nicotine patch + capsule placebo, and patch placebo + capsule placebo, under a cross-over design in Periods 1 and 2. In Part 2 (Period 3), HC participants are randomly assigned to receive either MK-4334 250 mg capsule + patch placebo or capsule placebo + patch placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotine patch

2015

Completed Phase 4

~6130

MK-4334

2022

Completed Phase 1

~40