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Memory Improvement Through Nicotine Dosing (MIND)

Recruiting

Nicotine has been shown to improve attention, learning, and memory. Researchers in this Phase II trial will test whether nicotine delivered via a transdermal (skin) patch may improve memory performance in older adults who are experiencing mild cognitive impairment (MCI).

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 90 Years All No
January 2017
December 2020
300

  • Subjective memory concern reported by participant, study partner, or doctor
  • Abnormal memory function
  • Mini-Mental State Examination score of 24-30
  • Clinical Dementia Rating of 0.5 (very mild dementia)
  • General cognition and functional performance such that a diagnosis of Alzheimer's cannot be made
  • Medications stable for at least 4 weeks; memantine (Namenda) is allowed if stable for at least 12 weeks
  • Geriatric Depression Scale score of 9 or less
  • Study partner who has contact on average 10 or more hours per week and can attend most visits
  • Adequate visual and auditory ability to allow neuropsychological testing
  • Good general health with no diseases, disorders, or significant abnormalities that could interfere with the study
  • If female, must be 2 years postmenopausal or surgically sterile
  • Completed six grades of education or has a good work history
  • Fluent in English

  • Regular use of tobacco products within the past year, including cigarettes, pipes, cigars, chewing tobacco, e-cigarettes, nicotine patches, gum, and sprays
  • Any significant neurologic disease, such as Alzheimer's, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis
  • History of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities
  • Major depression; bipolar disorder within the past year; or psychotic features, agitation, or behavioral problems within past 3 months
  • History of schizophrenia
  • History of alcohol or substance abuse or dependence within the past 2 years
  • Significant or unstable medical condition, including uncontrolled hypertension or diabetes, or significant heart, lung, kidney, liver, endocrine, or other systemic disease
  • History within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
  • Significant abnormalities in B12 or thyroid function tests that might interfere with the study
  • Significant abnormalities in screening laboratories or electrocardiogram
  • Residence in skilled nursing facility
  • Use of centrally acting anti-cholinergic drugs, such as donepezil (Aricept) and rivastigmine (Exelon), or other excluded medications
  • Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer

Participants will be randomized to wear either a nicotine skin patch or a placebo for 2 years during waking hours. The nicotine dosage will start at 3.5 mg and increase over 6 weeks to 21 mg for the majority of the trial, tapering down in the final month. Researchers will measure changes in attention, cognitive impairment, memory, mood, and functional performance. Researchers will also look at changes in biomarkers in cerebrospinal fluid and on brain imaging of some participants.

For more information about the MIND study or study sites, visit www.mindstudy.org or contact ATRI Recruitment at mind-participate@usc.edu.

Name City State Zip Status Primary Contact
Perseverance Research Center
Scottsdale Arizona 85254 Recruiting Brandon McCravey
480-471-6132
bmccravey@prcresearcheducation.com
Central Arkansas Veterans HS
North Little Rock Arkansas 72205 Recruiting Kalpana Padala
501-257-2044
Kalpana.padala@va.gov
USC Rancho Los Amigos
Downey California 90242 Recruiting Marielena Meza

MarielenaM@ranchoresearch.org
Sharp Mesa Vista Hospital
San Diego California 92123 Recruiting Joshua Barder
858-836-8350
joshua.barder@sharp.com
Syrentis Clinical Research
Santa Ana California 92705 Recruiting Rebeca Sanchez
714-542-3008
rsanchezCRC@gmail.com
Associated Neurologists
Danbury Connecticut 06810 Recruiting Dawn Morsey
203-748-2551
Georgetown University
Washington District of Columbia 200072145 Recruiting Virgilio Garcia
202-687-9078
vag27@georgetown.edu
Brain Matters Research
Delray Beach Florida 33445 Recruiting Jetliza Lesmes
561-374-8461
jlesmes@brainmattersresearch.com
Miami Jewish Health Systems
Miami Florida 33137 Recruiting Elizabeth Suarez
305-514-8710
ESuarez@miamijewishhealth.org
Advanced Clinical Research
Meridian Idaho 83642 Recruiting Adriana Freund
208-955-9030
afreund@acr-research.com
Northwestern University
Chicago Illinois 606113010 Recruiting Jordan Robson
312-503-5212
jordan.robson@northwestern.edu
University of Iowa
Iowa City Iowa 52242 Recruiting Karen Ekstam-Smith
319-353-5158
karen-ekstam@uiowa.edu
Acadia Hospital
Bangor Maine 04402 Recruiting Kathleen Chamberlain
207-973-7726
kmchamberlain@emhs.org.org
Donald S. Marks
Plymouth Massachusetts 02360 Recruiting Shelby Lydon
508-746-5060
shelbyl@dsmmdpc.com
University of New Mexico
Albuquerque New Mexico 87106 Recruiting Justine Saavedra
505-272-5631
jlsaavedra@salud.unm.edu
New York University Medical Center
New York New York 100166055 Recruiting Shannon Chen
212-263-5845
shannon.chen@nyumc.org
Mount Sinai School of Medicine
New York New York 100296552 Recruiting Allison Ardolino
212-241-0438
allison.ardolino@mssm.edu
Integrative Clinical Trials
New York New York 11229 Recruiting Svetlana Netrebchuk
718-444-7774
svetlana.netrebchuk@iclinicaltrials.net
Wake Forest University Health Sciences
Winston-Salem North Carolina 27157 Active, not recruiting

Ohio State University
Columbus Ohio 43210 Recruiting Jennifer Icenhour
614-293-6882
Jennifer.icenhour@osumc.edu
Tulsa Clinical Research
Tulsa Oklahoma 74104 Recruiting John Parsons

jparsons@tulsaclinicalresearch.com
LeHigh Valley Hospital
Allentown Pennsylvania 18105 Recruiting Andrew Orzel
610-402-8447
Andrew.Orzel@lvhn.org
Penn State Hershey Medical Center
Hershey Pennsylvania 17033 Recruiting Leonard Kishel
717-531-0003
lkishel@pennstatehealth.psu.edu
Roper St. Francis Hospital
Charleston South Carolina 294011113 Recruiting Allison Lapp
843-724-2302
allison.lapp@rsfh.com
Vanderbilt University Medical Center
Nashville Tennessee 37212 Recruiting Kate Kelly
615-875-0955
Katerri.m.kelly@vumc.org
Houston Methodist Neurological Institute
Houston Texas 77030 Recruiting Jennifer Garrett
713-441-9484
jmgarrett@houstonmethodist.org
Glenn Biggs Institute at the University of Texas Health
San Antonio Texas 78229 Recruiting Amy Saklad
210-567-8229
SakladA@uthscsa.edu
University of Utah
Salt Lake City Utah 84112 Recruiting Anna Bradford
801-585-9450
anna.bradford@utah.edu
University of Washington
Seattle Washington 98195 Recruiting Yeung Tutterrow
206-897-6350
ylt2@uw.edu
VA Puget Sound
Seattle Washington 98195 Recruiting Anita Ranta
206-764-2339
rantaa@uw.edu
University of Wisconsin
Madison Wisconsin 53706 Recruiting Alice (Yanmin) Li
608-263-4290
ali@clinicaltrials.wisc.edu

University of Southern California

  • National Institute on Aging (NIA)
  • Vanderbilt University
  • Alzheimer's Therapeutic Research Institute

Name Role Affiliation
Paul Aisen, MD Study Director USC Alzheimer's Therapeutic Research Institute (ATRI)
Paul Newhouse, MD Study Director Vanderbilt University

Name Phone Email
ATRI Recruitment mind-participate@usc.edu

NCT02720445

Long-Term Nicotine Treatment of Mild Cognitive Impairment