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Memory Improvement Through Nicotine Dosing (MIND) Study (MIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02720445
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : November 13, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Vanderbilt University
Alzheimer's Therapeutic Research Institute
Information provided by (Responsible Party):
Paul Aisen, University of Southern California

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: Nicotine Transdermal Patch Drug: Placebo Patch Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-Term Nicotine Treatment of Mild Cognitive Impairment
Actual Study Start Date : January 13, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Nicotine Transdermal Patch
150 participants will wear nicotine transdermal patches during waking hours. Active dose will titrate up from 3.5mg to 21mg in the first 6 weeks of treatment, remain at 21mg for 22.5 months, and then taper down in the final month of treatment
Drug: Nicotine Transdermal Patch
21mg Nicotine transdermal patches worn during waking hours. Active dose will titrate up from 3.5mg to 21mg in the first 6 weeks of treatment, remain at 21mg for 22.5 months, and then taper down in the final month of treatment.

Placebo Comparator: Placebo Patch
150 participants will wear matching placebo patches during waking hours.
Drug: Placebo Patch
Matching placebo patches worn during waking hours.




Primary Outcome Measures :
  1. Change from Baseline of the Conners Continuous Performance Task (CPT) to Month 25 [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Change from Baseline in Mild Cognitive Impairment - Clinical Global Impression of Change (MCI-CGIC) to Month 25 [ Time Frame: 2 years ]
    The MCI-CGIC is the MCI version of the clinician's global impression of change. In this trial it will measure change in the participant's condition between the baseline visit and subsequent visits.

  2. Change from Baseline in Cogstate Brief Battery (CBB) to Month 25 [ Time Frame: 2 years ]
    This battery will be used for the purpose of assessing the cognitive status of the participants and will assist in documenting multiple domains of cognitive impairment.

  3. Change in Baseline in New York University (NYU) Paragraph Recall to Month 25 [ Time Frame: 2 years ]
    This test measures immediate and delayed verbal recall of a brief story.

  4. Change from Baseline in Clinical Dementia Rating Scale (CDR) - Sum of Boxes (SOB) to Month 25 [ Time Frame: 2 years ]
    The is a clinical scale that rates the severity of dementia as absent, questionable, mild, moderate, or severe.

  5. Change in Baseline in Geriatric Depression Scale (GDS) to Month 25 [ Time Frame: 2 years ]
    This is a 30-item self-report assessment used to identify depression in the elderly.

  6. Change in Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) to Month 25 [ Time Frame: 2 years ]
    This scale is an inventory developed to assess functional performance in participantss with Alzheimer's disease.

  7. Change from Baseline in Older Adult Self Report (OASR) / Older Adult Behavior Checklist (OABCL) to Month 25 [ Time Frame: 2 years ]
    The OASR/OABCL is a general index of psychopathologic symptoms and signs that is specifically relevant to elderly individuals and is developmentally appropriate, covers a wide range of psychopathologic signs and symptoms, and functional measures. It allows multi-informant perspective (both patient and informant). The items are focused on common elderly emotional, functional, or medical problems. The OASR is completed by the participant and the companion OABCL is completed by the informant.


Other Outcome Measures:
  1. Change from Baseline in Cerebral Spinal Fluid (CSF) Biomarkers to Month 25 [ Time Frame: 2 years ]
    CSF will be performed in approximately 50 participants each

  2. Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) to Month 25 [ Time Frame: 2 years ]


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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 14
  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 the participant
  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 the required 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720445


Contacts
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Contact: ATRI Recruitment mind-participate@usc.edu

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Locations
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United States, Arizona
Perseverance Research Center Recruiting
Scottsdale, Arizona, United States, 85254
Contact: Laura Christians    480-471-6132    lchristians@prcresearcheducation.com   
Principal Investigator: Feras Aldaoud, MD         
United States, Arkansas
Central Arkansas Veterans Healthcare System Recruiting
North Little Rock, Arkansas, United States, 72205
Contact: Kalpana Padala    501-257-2044    Kalpana.padala@va.gov   
Principal Investigator: Kalpana Padala, MD         
United States, California
USC Rancho Los Amigos Recruiting
Downey, California, United States, 90242
Contact: Marielena Meza       MarielenaM@ranchoresearch.org   
Principal Investigator: Freddi Segal-Gidan, PhD         
Hoag Memorial Hospital Presbyterian Not yet recruiting
Newport Beach, California, United States, 92663
Principal Investigator: William Shankle, MD         
Sharp Mesa Vista Hospital Not yet recruiting
San Diego, California, United States, 92123
Principal Investigator: Michael Plopper, MD         
Syrentis Clinical Research Recruiting
Santa Ana, California, United States, 92705
Contact: Rebeca Sanchez    714-542-3008    rsanchezCRC@gmail.com   
Principal Investigator: John Duffy, MD         
United States, Connecticut
Associated Neurologists Recruiting
Danbury, Connecticut, United States, 06810
Contact: Janet Mauro    203-748-2551 ext 351    jmauro@assocneuro.com   
Principal Investigator: Samuel Markind, MD, FAAN         
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 200072145
Contact: Margaret Bassett    202-687-2352    mjb438@georgetown.edu   
Principal Investigator: Raymond Scott Turner, MD, PhD         
United States, Florida
C & R Research Services Not yet recruiting
Coral Gables, Florida, United States, 33134
Principal Investigator: Jorge Santander, MD         
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Contact: Jetliza Lesmes    561-374-8461 ext 110    jlesmes@brainmattersresearch.com   
Principal Investigator: Mark Brody, MD, CPI         
Miami Jewish Health Systems Recruiting
Miami, Florida, United States, 33137
Contact: Eileen Diaz       Ediaz1@miamijewishhealth.org   
Principal Investigator: Marc Agronin, MD         
United States, Georgia
Augusta University Movement and Memory Disorders Not yet recruiting
Augusta, Georgia, United States, 30912
Principal Investigator: John Morgan, MD         
United States, Idaho
Advanced Clinical Research Recruiting
Meridian, Idaho, United States, 83642
Contact: Adriana Freund    208-955-9030    afreund@acr-research.com   
Principal Investigator: Mark Allen Turner, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 606113010
Contact: Brittanie Muse    312-503-5674    brittanie.muse@northwestern.edu   
Principal Investigator: Ian Grant, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Karen Ekstam-Smith    319-353-5158    karen-ekstam@uiowa.edu   
Principal Investigator: Delwyn Miller, MD         
United States, Kansas
Cypress Medical Research Center Withdrawn
Wichita, Kansas, United States, 67226
United States, Maine
Acadia Hospital Recruiting
Bangor, Maine, United States, 04402
Contact: Krysta Anderson       keanderson@emhs.org   
Principal Investigator: Clifford Singer, MD         
United States, Massachusetts
Tufts Medical Center Withdrawn
Boston, Massachusetts, United States, 02111
Donald S. Marks, MD, PC Recruiting
Plymouth, Massachusetts, United States, 02360
Contact: Shelby Lydon    508-746-5060    shelbyl@dsmmdpc.com   
Principal Investigator: Donald Marks, MD, PC         
United States, Michigan
Bronson Lakeview Hospital Withdrawn
Kalamazoo, Michigan, United States, 49079
United States, New Jersey
The Cognitive and Research Center of New Jersey Not yet recruiting
Springfield, New Jersey, United States, 07081
Principal Investigator: Michelle Papka, PhD         
Advanced Memory Research Institute of New Jersey Not yet recruiting
Toms River, New Jersey, United States, 08755
Principal Investigator: Sanjiv Sharma, MD         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Justine Saavedra    505-272-5631    jlsaavedra@salud.unm.edu   
Principal Investigator: Gary Rosenberg, MD         
United States, New York
New York University Medical Center Recruiting
New York, New York, United States, 100166055
Contact: Anaztasia Ulysse    212-263-0771    Anaztasia.Ulysse@nyumc.org   
Principal Investigator: Arjun Vijay Masurkar, MD, PhD         
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 100296552
Contact: Allison Ardolino    212-241-0438    allison.ardolino@mssm.edu   
Principal Investigator: Clara Li, PhD         
Integrative Clinical Trials Recruiting
New York, New York, United States, 11229
Contact: Khatuna Tsotsoria    718-444-7774 ext 122    khatuna.tsotsoria@iclinicaltrials.net   
Principal Investigator: Inna Yuryev-Golger, MD         
SUNY Upstate Medical University Not yet recruiting
Syracuse, New York, United States, 13210
Principal Investigator: Sharon Brangman, MD         
United States, North Carolina
Wake Forest University Health Sciences Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Rapid Medical Research Withdrawn
Cleveland, Ohio, United States, 44122
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Jennifer Icenhour    614-293-6882    Jennifer.icenhour@osumc.edu   
Principal Investigator: Douglas Scharre, MD         
United States, Oklahoma
Tulsa Clinical Research Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: John Parsons       jparsons@tulsaclinicalresearch.com   
Principal Investigator: Michael Karathanos, MD         
United States, Oregon
Providence Brain and Spine Institute Not yet recruiting
Portland, Oregon, United States, 97225
Principal Investigator: Ho-Yann Jong, MD         
United States, Pennsylvania
LeHigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Andrew Orzel    610-402-8447    Andrew.Orzel@lvhn.org   
Contact: Thomas Eames    610-402-8786    thomas.eames@lvhn.org   
Principal Investigator: Alison Walsh, MD         
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Leonard Kishel    717-531-0003 ext 289860    lkishel@pennstatehealth.psu.edu   
Principal Investigator: Paul Eslinger, PhD         
United States, South Carolina
Roper St. Francis Hospital Recruiting
Charleston, South Carolina, United States, 294011113
Contact: Allison Lapp    843-724-2302    allison.lapp@rsfh.com   
Principal Investigator: Jacobo Mintzer, MD, MBA         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Amy Boegel    615-936-0231    amy.r.boegel@vanderbilt.edu   
Principal Investigator: Patricia Serrano-Andrews, MD         
United States, Texas
Houston Methodist Neurological Institute Recruiting
Houston, Texas, United States, 77030
Contact: Jennifer Garrett    713-441-9484    jmgarrett@houstonmethodist.org   
Principal Investigator: Joseph Masdeu, MD, PhD         
Glenn Biggs Institute at the University of Texas Health Recruiting
San Antonio, Texas, United States, 78229
Contact: Amy Saklad    210-567-8229    SakladA@uthscsa.edu   
Principal Investigator: Sudha Seshadri, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Anna Bradford    801-585-9450    anna.bradford@utah.edu   
Principal Investigator: Scott Langenecker, PhD         
United States, Washington
University of Washington / VA Pudget Sound Recruiting
Seattle, Washington, United States, 98195
Contact: Anita Ranta    206-764-2339    rantaa@uw.edu   
Principal Investigator: Elaine Peskind, MD         
University of Washington Memory and Brain Wellness Center Recruiting
Seattle, Washington, United States, 98195
Contact: Yeung Tutterrow    206-897-6350    ylt2@uw.edu   
Principal Investigator: Michael Persenaire, MD         
Kingfisher Cooperative, LLC Not yet recruiting
Spokane, Washington, United States, 99202
Principal Investigator: David Greeley, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53706
Contact: Alice (Yanmin) Li    608-263-4290    ali@clinicaltrials.wisc.edu   
Principal Investigator: Sanjay Asthana, MD         
Sponsors and Collaborators
University of Southern California
National Institute on Aging (NIA)
Vanderbilt University
Alzheimer's Therapeutic Research Institute
Investigators
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Study Director: Paul Aisen, MD USC Alzheimer's Therapeutic Research Institute (ATRI)
Study Director: Paul Newhouse, MD Vanderbilt University

Additional Information:
Publications:
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Responsible Party: Paul Aisen, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02720445     History of Changes
Other Study ID Numbers: ATRI-002-NIC
R01AG047992 ( U.S. NIH Grant/Contract )
131918 ( Other Identifier: Food and Drug Administration (FDA) )
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Paul Aisen, University of Southern California:
Alzheimer's Disease
Nicotine
Transdermal Patch
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action