Memory Improvement Through Nicotine Dosing (MIND) Study



Status:Recruiting
Conditions:Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:55 - 90
Updated:3/7/2019
Start Date:January 13, 2017
End Date:December 2019
Contact:ATRI Recruitment
Email:mind-participate@usc.edu

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Long-Term Nicotine Treatment of Mild Cognitive Impairment

The purpose of the study is to see if daily transdermal nicotine is able to produce a
significant cognitive, clinical and functional improvement in participants with MCI. Neuronal
nicotinic receptors have long been known to play a critical role in memory function in
preclinical studies, with nicotine improving attention, learning, and memory function.

The study will enroll 300 participants for a 2 year period. Participants will be randomized
(50:50) to either the transdermal nicotine, beginning at 7mg/day, and increasing to 21mg/day,
or placebo skin patch.


Inclusion Criteria:

1. Participant must have a subjective memory concern as reported by participant, study
partner, or clinician

2. Abnormal memory function documented by scoring within the education adjusted ranges on
the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory
Scale - Revised:

- less than or equal to 11 for 16 or more years of education

- less than or equal to 9 for 8 - 15 years of education

- less than or equal to 6 for 0 - 7 years of education

3. Mini-Mental State Exam score between 24 and 30, inclusive

4. Clinical Dementia Rating (CDR) Global = 0.5. Memory Box score must be at least 0.5

5. General cognition and functional performance sufficiently preserved such that a
diagnosis of Alzheimer's disease dementia cannot be made by the site physician at the
time of the screening visit

6. Age 55-90 (inclusive)

7. Stable permitted medications for 4 weeks or longer as specified in Section 6,
including:

• Memantine and cholinesterase inhibitors are allowable if stable for 12 weeks prior
to screen

8. Geriatric Depression Scale score of less than or equal to 9

9. Study Partner is available who has frequent contact with the participant (e.g. an
average of 10 hours per week or more), and can accompany the participant to most
visits to answer questions about theparticipant

10. Adequate visual and auditory acuity to allow neuropsychological testing

11. Good general health with no additional diseases/disorders expected to interfere with
the study

12. Participant is not pregnant, lactating, or of childbearing potential (i.e. women must
be two years post-menopausal or surgically sterile)

13. Completed six grades of education or has a good work history

14. Must speak English fluently

Exclusion Criteria:

1. Regular use of tobacco products within the past year, such as smoking (cigarettes,
pipes, cigars, etc.) or use of other nicotine products (chewing tobacco, e-cigarettes,
nicotine patches, gum, sprays, etc.).

2. Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson's
disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus,
brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma,
multiple sclerosis, or history of significant head trauma followed by persistent
neurologic deficits or known structural brain abnormalities.

3. Major depression, bipolar disorder as described in DSM-V within the past 1 year or
psychotic features, agitation or behavioral problems within 3 months, which could lead
to difficulty complying with the protocol

4. History of schizophrenia (DSM V criteria)

5. History of alcohol or substance abuse or dependence within the past 2 years (DSM V
criteria)

6. Clinically significant or unstable medical condition, including uncontrolled
hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal,
hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may
either put the participant at risk because of participation in the study, or influence
the results, or the participant's ability to participate in the study.

7. Has had a 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

8. Clinically significant abnormalities in B12 or TFTs (Thyroid Function Tests) that
might interfere with the study. A low B12 is exclusionary, unless follow-up labs
(homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not
physiologically significant.

9. Clinically significant abnormalities in screening laboratories or ECG.

10. Residence in skilled nursing facility.

11. Use of any excluded medication as described in the protocol, including:

- Use of centrally acting anti-cholinergic drugs

- Use of any investigational drugs within 30 days or 5 half-lives, whichever is
longer, prior to screening.

12. For CSF sub-study participants, a current blood clotting or bleeding disorder, or
significantly abnormal PT or PTT (partial thromboplastin time) at screening

13. For MRI sub-study participants, contraindications for MRI studies, including
claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker.

14. Patients whom the Site PI deems to be otherwise ineligible.
We found this trial at
32
sites
Scottsdale, Arizona 85254
Principal Investigator: Feras Aldaoud, MD
Phone: 480-471-6132
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Tinatin Chabrashvili, MD, PhD
Phone: 617-636-7606
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Delwyn Miller, MD
Phone: 319-353-5158
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Meghan Riddle, MD
Phone: 615-875-0955
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Sara Weisenbach, PhD
Phone: 801-585-9450
University of Utah Research is a major component in the life of the U benefiting...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Michael Persenaire, MD
Phone: 206-897-6350
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Gary Rosenberg, MD
Phone: 505-272-5631
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Principal Investigator: Alison Walsh, MD
Phone: 610-402-8447
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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Bangor, Maine 04401
Principal Investigator: Clifford Singer, MD
Phone: 207-973-7726
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Charleston, South Carolina 29401
Principal Investigator: Jacobo Mintzer, MD, MBA
Phone: 843-724-2302
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Ian Grant, MD
Phone: 312-503-5212
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Cleveland, Ohio 44122
Principal Investigator: Toby Briskin, MD
Phone: 216-682-0320
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Douglas Scharre, MD
Phone: 614-293-6882
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Danbury, Connecticut 06810
Principal Investigator: Samuel Markind, MD, FAAN
Phone: 203-748-2551
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Delray Beach, Florida 33445
Principal Investigator: Mark Brody, MD, CPI
Phone: 561-374-8461
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7601 Imperial Highway
Downey, California 90242
Principal Investigator: Mindy Aisen, MD
Phone: 562-385-7463
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Hershey, Pennsylvania 17033
Principal Investigator: Paul Eslinger, PhD
Phone: 717-531-0003
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Houston, Texas 77030
Principal Investigator: Joseph Masdeu, MD, PhD
Phone: 713-441-9484
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601 John Street
Kalamazoo, Michigan 49079
Principal Investigator: Nadeem Mirza, MD
Phone: 269-337-4324
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Sanjay Asthana, MD
Phone: 608-263-4290
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Meridian, Idaho 83642
Principal Investigator: Mark Allen Turner, MD
Phone: 208-955-9030
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Miami, Florida 33137
Principal Investigator: Marc Agronin, MD
Phone: 305-514-8710
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New York, New York 10021
Principal Investigator: Arjun Vijay Masurkar, MD, PhD
Phone: 212-263-5845
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New York, New York 10029
Principal Investigator: Clara Li, PhD
Phone: 212-241-0438
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2388 Ocean Avenue
New York, New York 11229
Principal Investigator: Inna Yuryev-Golger, MD
Phone: 718-444-7774
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4300 West 7th Street
North Little Rock, Arkansas 72205
Phone: 501-257-2044
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San Antonio, Texas 78229
Principal Investigator: Sudha Seshadri, MD
Phone: 210-567-8229
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Santa Ana, California 92705
Principal Investigator: John Duffy, MD
Phone: 714-542-3008
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Tulsa, Oklahoma 74104
Principal Investigator: Michael Karathanos, MD
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Principal Investigator: Raymond Scott Turner, MD, PhD
Phone: 202-687-9078
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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Wichita, Kansas 67226
Principal Investigator: Jeffrey Davis, MD
Phone: 316-440-7000
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Mia Yang, MD
Phone: 336-713-8462
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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