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Nicotinic Acetylcholine Receptor Agonist
Active Nicotine Group for Memory Disorders
Phase 1
Waitlist Available
Led By Paul Newhouse, MD
Research Sponsored by National Institute on Aging (NIA)
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 13 months
Awards & highlights
Study Summary
The purpose of this 12-month study is to determine whether nicotine, administered in the form of nicotine patches, can improve symptoms of memory loss in some people experiencing mild memory problems (referred to in this study as "mild cognitive impairment" or MCI).
Eligible Conditions
- Memory Disorders
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of transdermal nicotine patch
Secondary outcome measures
Change in cognitive performance
Change in global functioning
Side effects data
From 2016 Phase 4 trial • 47 Patients • NCT01362959100%
Electrolyte disturbance
100%
Gastrointestinal event
100%
Cardiovascular
100%
Other adverse events
31%
Pulmonary
23%
Renal
8%
Death due to respiratory failure
8%
Reintubation
8%
Ischaemic colitis
4%
Stoma necrosis
4%
Duodenal perforation
4%
Asystole
4%
Death due to septic shock
4%
haemorrhagic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Nicotine Replacement
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Nicotine GroupExperimental Treatment1 Intervention
Blinded active nicotine for first six months of study; open-label active nicotine for second six months
Group II: Placebo GroupPlacebo Group1 Intervention
Placebo for first six months of study; moved to open-label active nicotine for second six months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)Lead Sponsor
1,665 Previous Clinical Trials
28,005,004 Total Patients Enrolled
19 Trials studying Memory Disorders
4,932 Patients Enrolled for Memory Disorders
Paul Newhouse, MDPrincipal InvestigatorUniversity of Vermont
4 Previous Clinical Trials
674 Total Patients Enrolled
Frequently Asked Questions
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