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

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ClinicalTrials.gov Identifier: NCT02720445
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : June 18, 2018
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

March 22, 2016
March 25, 2016
June 18, 2018
January 13, 2017
December 2019   (Final data collection date for primary outcome measure)
Change from Baseline of the Conners Continuous Performance Task (CPT) to Month 25 [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT02720445 on ClinicalTrials.gov Archive Site
  • 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.
  • 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) and Older Adult Behavior Checklist (OABCL) to Month 25 [ Time Frame: 2 years ]
    The test 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.
  • 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 ]
Same as current
 
Memory Improvement Through Nicotine Dosing (MIND) Study
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Mild Cognitive Impairment
  • 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.
  • Drug: Placebo Patch
    Matching placebo patches worn during waking hours.
  • 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
    Intervention: Drug: Nicotine Transdermal Patch
  • Placebo Comparator: Placebo Patch
    150 participants will wear matching placebo patches during waking hours.
    Intervention: Drug: Placebo Patch

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Same as current
December 2019
December 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
55 Years to 90 Years   (Adult, Older Adult)
No
Contact: ATRI Recruitment mind-participate@usc.edu
United States
 
 
NCT02720445
ATRI-002-NIC
R01AG047992 ( U.S. NIH Grant/Contract )
131918 ( Other Identifier: Food and Drug Administration (FDA) )
Yes
Not Provided
Plan to Share IPD: Yes
Paul Aisen, University of Southern California
University of Southern California
  • National Institute on Aging (NIA)
  • Vanderbilt University
  • Alzheimer's Therapeutic Research Institute
Study Director: Paul Aisen, MD USC Alzheimer's Therapeutic Research Institute (ATRI)
Study Director: Paul Newhouse, MD Vanderbilt University
University of Southern California
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP