Memory Improvement Through Nicotine Dosing (MIND)

What Is This Study About?

Nicotine has been shown to improve attention, learning, and memory. In this trial, researchers will test whether nicotine delivered via a transdermal (skin) patch improves memory performance in older adults who are have mild cognitive impairment. Participants will be randomly assigned to wear either a nicotine skin patch or a placebo for two years during waking hours. Researchers will measure changes in attention, cognitive impairment, memory, mood, and other daily tasks. They will also look for changes in biomarkers in cerebrospinal fluid and on brain imaging of some participants.

Do I Qualify To Participate in This Study?

Must have:

• 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 four 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 two years postmenopausal or surgically sterile
• Completed six grades of education or has a good work history
• Fluent in English

Must NOT have:

• 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 three months
• History of schizophrenia
• History of alcohol or substance abuse or dependence within the past two 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 five 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 five half-lives, whichever is longer

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Study Contact
ATRI Recruitment
mind-participate@usc.edu

Who Is the General Study Contact?

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

Where Is This Study Located?

Arizona
Perseverance Research Center Scottsdale, AZ 85254 Recruiting Laura Christians 480-471-6132 lchristians@prcresearcheducation.com
Arkansas
Central Arkansas Veterans HS North Little Rock, AR 72205 Recruiting Kalpana Padala 501-257-2044 Kalpana.padala@va.gov
California
USC Rancho Los Amigos Downey, CA 90242 Active, not recruiting
Hoag Memorial Hospital Presbyterian Newport Beach, CA 92663 Recruiting Adrienne Swietlikowski 973-850-4622 adrienne.swietlikowski@hoag.org
Sharp Mesa Vista Hospital San Diego, CA 92123 Recruiting Miriam Silva 858-836-8350 Miriam.Silva@sharp.com
Syrentis Clinical Research Santa Ana, CA 92705 Recruiting Rebeca Sanchez 714-542-3008 rsanchezCRC@gmail.com
Connecticut
Associated Neurologists Danbury, CT 06810 Recruiting Dawn Morsey 203-748-2551 ext 377 dawnmarie.morsey@wchn.org
District of Columbia
Georgetown University Washington, DC 200072145 Recruiting Margaret Bassett 202-687-2352 mjb438@georgetown.edu
Florida
JEM Research Institute Atlantis, FL 33462 Recruiting Belinda Russell 561-968-2933 brussell@jemri.net
Brain Matters Research Delray Beach, FL 33445 Recruiting Jetliza Lesmes 561-381-9060 jlesmes@ergclinical.com
Miami Jewish Health Systems Miami, FL 33137 Recruiting Eileen Diaz 305-514-8710 Ediaz1@miamijewishhealth.org
Brain Matters Research Stuart, FL 34997 Recruiting Jetliza Lesmes 561-381-9060 jlesmes@ergclinical.com
Georgia
Augusta University Augusta, GA 30912 Recruiting Paula Jackson 706-721-4152 paujackson@augusta.edu
Idaho
Advanced Clinical Research Meridian, ID 83642 Recruiting Adriana Freund 208-955-9030 afreund@acr-research.com
Illinois
Northwestern University Chicago, IL 606113010 Recruiting Brittanie Muse 312-503-5674 britannie.muse@northwestern.edu
Iowa
University of Iowa Iowa City, IA 52242 Recruiting Karen Ekstam-Smith 319-353-5158 karen-ekstam@uiowa.edu
Maine
Acadia Hospital Bangor, ME 04402 Recruiting Krysta Anderson 207-973-7596 keanderson@emhs.org
Massachusetts
Donald S. Marks Plymouth, MA 02360 Recruiting Shelby Lydon 508-746-5060 shelbyl@dsmmdpc.com
New Jersey
Advanced Memory Research Institute Toms River, NJ 08755 Recruiting Anna Brocco 732-341-9500 ABrocco@amrinj.com
New Mexico
University of New Mexico Albuquerque, NM 87106 Recruiting Jill Prestopnik 505-272-3735 jprestopnik@salud.unm.edu
New York
University of Buffalo (UBMD Neurology) Buffalo, NY 14203 Recruiting Connie Brand 716-323-0549 conniebr@buffalo.edu
Clarity Clinical Research East Syracuse, NY 13057 Recruiting Christine Hall 315-760-5905 x702 cshall@clarityclinicalresearch.com
New York University Medical Center New York, NY 100166055 Recruiting Anaztasia Ulysse 212-263-0771 Anaztasia.Ulysse@nyumc.org
Mount Sinai School of Medicine New York, NY 100296552 Recruiting Allison Ardolino 212-241-0438 allison.ardolino@mssm.edu
Integrative Clinical Trials New York, NY 11229 Recruiting Khatuna Tsotsoria 718-444-7774 x122 khatuna.tsotsoria@iclinicaltrials.net
SUNY-Upstate Medical Center Syracuse, NY 13210 Recruiting Colleen Dillenbeck 315-464-3285 GeriResearch@upstate.edu
North Carolina
Wake Forest University Health Sciences Winston-Salem, NC 27157 Active, not recruiting
Ohio
Ohio State University Columbus, OH 43210 Recruiting Jennifer Icenhour 614-293-6882 Jennifer.icenhour@osumc.edu
Oklahoma
Central States Research Tulsa, OK 74104 Recruiting Christy Lisenbee 918-955-4222 christyl@centralstatesresearch.com
Oregon
Providence Brain and Spine Institute Portland, OR 97225 Recruiting Lynette Currie 503-216-1034 lynette.currie@providence.org
Pennsylvania
LeHigh Valley Hospital Allentown, PA 18105 Recruiting Andrew Orzel 610-402-8447 Andrew.Orzel@lvhn.org
Penn State Hershey Medical Center Hershey, PA 17033 Recruiting Leonard Kishel 717-531-0003 ext 289860 lkishel@pennstatehealth.psu.edu
South Carolina
Roper St. Francis Hospital Charleston, SC 294011113 Recruiting Allison Lapp 843-724-2214 allison.lapp@rsfh.com
Tennessee
Neurology Clinic, P.C. Cordova, TN 38018 Recruiting Rebecca Sparks 901-866-9252 rsparks@neuroclinic.org
Vanderbilt University Medical Center Nashville, TN 37212 Recruiting Amy Boegel 615-875-0955 amy.r.boegel@vanderbilt.edu
Texas
Houston Methodist Neurological Institute Houston, TX 77030 Recruiting Jennifer Garrett 713-441-9484 jmgarrett@houstonmethodist.org
Glenn Biggs Institute at the University of Texas Health San Antonio, TX 78229 Recruiting Amy Saklad 210-567-8229 SakladA@uthscsa.edu
Utah
University of Utah Salt Lake City, UT 84112 Recruiting Anna Bradford 801-585-9450 anna.bradford@utah.edu
Washington
University of Washington Seattle, WA 98195 Recruiting Yeung Tutterrow 206-897-6350 ylt2@uw.edu
VA Puget Sound Seattle, WA 98195 Recruiting Anita Ranta 206-764-2339 rantaa@uw.edu
Kingfisher Cooperative, LLC Spokane, WA 99202 Recruiting Victoria Karschney 509-747-5615 VK@Kingfishercoop.com
Wisconsin
University of Wisconsin Madison, WI 53706 Recruiting Alice (Yanmin) Li 608-263-4290 ali@clinicaltrials.wisc.edu

Who Sponsors This Study?

Lead: University of Southern California

Collaborator Sponsor

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

Source: ClinicalTrials.gov ID: NCT02720445