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 |
- 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.
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 | |
---|---|---|
ATRI Recruitment | mind-participate@usc.edu |
Long-Term Nicotine Treatment of Mild Cognitive Impairment
- Newhouse PA, Potter A, Corwin J, Lenox R. Age-related effects of the nicotinic antagonist mecamylamine on cognition and behavior. Neuropsychopharmacology. 1994 Apr;10(2):93-107.
- Newhouse P, Kellar K, Aisen P, White H, Wesnes K, Coderre E, Pfaff A, Wilkins H, Howard D, Levin ED. Nicotine treatment of mild cognitive impairment: a 6-month double-blind pilot clinical trial. Neurology. 2012 Jan 10;78(2):91-101. doi: 10.1212/WNL.0b013e31823efcbb.
- Dumas J, Hancur-Bucci C, Naylor M, Sites C, Newhouse P. Estrogen treatment effects on anticholinergic-induced cognitive dysfunction in normal postmenopausal women. Neuropsychopharmacology. 2006 Sep;31(9):2065-78. Epub 2006 Feb 15.
- Newhouse PA, Dumas J, Hancur-Bucci C, Naylor M, Sites CK, Benkelfat C, Young SN. Estrogen administration negatively alters mood following monoaminergic depletion and psychosocial stress in postmenopausal women. Neuropsychopharmacology. 2008 Jun;33(7):1514-27. Epub 2007 Aug 15.
- Newhouse PA, Sunderland T, Tariot PN, Blumhardt CL, Weingartner H, Mellow A, Murphy DL. Intravenous nicotine in Alzheimer's disease: a pilot study. Psychopharmacology (Berl). 1988;95(2):171-5.