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

This study is currently recruiting participants.
Verified October 2017 by Paul Aisen, University of Southern California
Sponsor:
ClinicalTrials.gov Identifier:
NCT02720445
First Posted: March 25, 2016
Last Update Posted: October 23, 2017
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.
Collaborators:
National Institute on Aging (NIA)
Vanderbilt University
Alzheimer's Therapeutic Research Institute
Information provided by (Responsible Party):
Paul Aisen, University of Southern California
  Purpose

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 Intervention Phase
Mild Cognitive Impairment Drug: Nicotine Transdermal Patch Drug: Placebo Patch Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Paul Aisen, University of Southern California:

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

Secondary Outcome Measures:
  • 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 subject's condition between the baseline visit and subsequent visits.

  • 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 subjects and will assist in documenting multiple domains of cognitive impairment.

  • 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.

  • 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.

  • 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.

  • 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 subjects with Alzheimer's disease.

  • 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 subject and the companion OABCL is completed by the informant.


Other Outcome Measures:
  • 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

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

Estimated Enrollment: 300
Actual Study Start Date: January 13, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Subject must have a subjective memory concern as reported by subject, 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 is allowable if stable for 12 weeks prior to screen

  8. No significant cerebrovascular disease: Modified Hachinski score of less than or equal to 4
  9. Geriatric Depression Scale score of less than or equal to 9
  10. Study Partner is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), and can accompany the subject to most visits to answer questions about the subject
  11. Adequate visual and auditory acuity to allow neuropsychological testing
  12. Good general health with no additional diseases/disorders expected to interfere with the study
  13. ECG without clinically significant abnormalities that would be expected to interfere with study participation
  14. Subject is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile)
  15. Completed six grades of education or has a good work history
  16. 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 subject at risk because of participation in the study, or influence the results, or the subject'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 cholinesterase inhibitors or centrally acting 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.
  Contacts and Locations
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
Contact: ATRI Recruitment mind-participate@usc.edu

Locations
United States, California
USC Rancho Los Amigos Recruiting
Downey, California, United States, 90242
Contact: Stephanie Bughi    562-385-7463    stephanieb@ranchoresearch.org   
Principal Investigator: Mindy Aisen, MD         
Syrentis Clinical Research Recruiting
Santa Ana, California, United States, 92705
Contact: Maria Medina    714-542-3008 ext 308    MMedinaCRC@gmail.com   
Principal Investigator: John Duffy, MD         
United States, District of Columbia
Georgetown University Recruiting
Washington, D.C., 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
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 Not yet recruiting
Miami, Florida, United States, 33137
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 606113010
Contact: Jordan Robson    312-503-5212    jordan.robson@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, Maine
Acadia Hospital Not yet recruiting
Bangor, Maine, United States, 04402
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 Not yet recruiting
New York, New York, United States, 100166055
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: Svetlana Netrebchuk    718-444-7774 ext 117    svetlana.netrebchuk@iclinicaltrials.net   
Principal Investigator: Inna Yuryev-Golger, MD         
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Clavenda Canty    336-713-5885    clcanty@wakehealth.edu   
Principal Investigator: Mia Yang, MD         
United States, Oklahoma
Tulsa Clinical Research Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: John Parsons       jparsons@tulsaclinicalresearch.com   
Principal Investigator: Ralph Richter, MD         
United States, South Carolina
Roper St. Francis Hospital Not yet recruiting
Charleston, South Carolina, United States, 294011113
United States, Tennessee
Meharry Medical College Not yet recruiting
Nashville, Tennessee, United States, 37208
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Sally Ross    615-875-0955    sally.ross@vanderbilt.edu   
Principal Investigator: Meghan Riddle, 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         
Sponsors and Collaborators
University of Southern California
National Institute on Aging (NIA)
Vanderbilt University
Alzheimer's Therapeutic Research Institute
Investigators
Study Director: Paul Aisen, MD USC Alzheimer's Therapeutic Research Institute (ATRI)
Study Director: Paul Newhouse, MD Vanderbilt University
  More Information

Additional Information:
Publications:
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 Submitted: March 22, 2016
First Posted: March 25, 2016
Last Update Posted: October 23, 2017
Last Verified: October 2017
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:
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