Phase
Condition
Dementia
Mental Disability
Alzheimer's Disease
Treatment
Placebo Patch
Nicotine Transdermal Patch
Clinical Study ID
Ages 55-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must have a subjective memory concern as reported by participant, studypartner, or clinician
Abnormal memory function documented by scoring within the education adjusted rangeson the Logical Memory II subscale (Delayed Paragraph Recall) from the WechslerMemory 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
Mini-Mental State Exam score between 24 and 30, inclusive
Clinical Dementia Rating (CDR) Global = 0.5. Memory Box score must be at least 0.5
General cognition and functional performance sufficiently preserved such that adiagnosis of Alzheimer's disease dementia cannot be made by the site physician atthe time of the screening visit
Age 55-90 (inclusive)
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 priorto screen
Geriatric Depression Scale score of less than or equal to 14
Study Partner is available who has frequent contact with the participant (e.g. anaverage of 10 hours per week or more), and can accompany the participant to mostvisits to answer questions about the participant
Adequate visual and auditory acuity to allow neuropsychological testing
Good general health with no additional diseases/disorders expected to interfere withthe study
Participant is not pregnant, lactating, or of childbearing potential (i.e. womenmust be two years post-menopausal or surgically sterile)
Completed six grades of education or has a good work history
Fluent in English or Spanish
Exclusion
Exclusion Criteria:
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.).
Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson'sdisease, multi-infarct dementia, Huntington's disease, normal pressurehydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder,subdural hematoma, multiple sclerosis, or history of significant head traumafollowed by persistent neurologic deficits or known structural brain abnormalities.
Major depression, bipolar disorder as described in DSM-V within the past 1 year orpsychotic features, agitation or behavioral problems within 3 months, which couldlead to difficulty complying with the protocol
History of schizophrenia (DSM V criteria)
History of alcohol or substance abuse or dependence within the past 2 years (DSM Vcriteria)
Clinically significant or unstable medical condition, including uncontrolledhypertension, 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, orinfluence the results, or the participant's ability to participate in the study.
Has had a history within the last 5 years of a primary or recurrent malignantdisease with the exception of non-melanoma skin cancers, resected cutaneous squamouscell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situprostate cancer with normal prostate-specific antigen post-treatment
Clinically significant abnormalities in B12 or TFTs (Thyroid Function Tests) thatmight interfere with the study. A low B12 is exclusionary, unless the requiredfollow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it isnot physiologically significant.
Clinically significant abnormalities in screening laboratories or ECG.
Residence in skilled nursing facility.
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 islonger, prior to screening.
For CSF sub-study participants, a current blood clotting or bleeding disorder, orsignificantly abnormal PT or PTT (partial thromboplastin time) at screening
For MRI sub-study participants, contraindications for MRI studies, includingclaustrophobia, the presence of metal (ferromagnetic) implants, or cardiacpacemaker.
Patients whom the Site PI deems to be otherwise ineligible.
Study Design
Connect with a study center
Perseverance Research Center
Scottsdale, Arizona 85254
United StatesSite Not Available
Perseverance Research Center
Scottsdale 5313457, Arizona 5551752 85254
United StatesSite Not Available
Central Arkansas Veterans Healthcare System
N. Little Rock, Arkansas 72205
United StatesSite Not Available
Central Arkansas Veterans Healthcare System
North Little Rock, Arkansas 72205
United StatesSite Not Available
Central Arkansas Veterans Healthcare System
North Little Rock 4124112, Arkansas 4099753 72205
United StatesSite Not Available
USC Rancho Los Amigos
Downey, California 90242
United StatesSite Not Available
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United StatesSite Not Available
Sharp Neurocognitive Research Center
San Diego, California 92123
United StatesSite Not Available
Syrentis Clinical Research
Santa Ana, California 92705
United StatesSite Not Available
USC Rancho Los Amigos
Downey 5343858, California 5332921 90242
United StatesSite Not Available
Sharp Neurocognitive Research Center
San Diego 5391811, California 5332921 92123
United StatesSite Not Available
Syrentis Clinical Research
Santa Ana 5392900, California 5332921 92705
United StatesSite Not Available
Nuvance Health Medical Practice Ct, Inc.; Associated Neurologists, PC
Danbury, Connecticut 06810
United StatesSite Not Available
Nuvance Health Medical Practice Ct, Inc.; Associated Neurologists, PC
Danbury 4832353, Connecticut 4831725 06810
United StatesSite Not Available
Georgetown University
Washington, District of Columbia 200072145
United StatesSite Not Available
Georgetown University
Washington, D.C., District of Columbia 200072145
United StatesSite Not Available
Georgetown University
Washington D.C. 4140963, District of Columbia 4138106 200072145
United StatesSite Not Available
JEM Research Institute
Atlantis, Florida 33462
United StatesSite Not Available
C & R Research Services
Coral Gables, Florida 33134
United StatesSite Not Available
Brain Matters Research
Delray Beach, Florida 33445
United StatesSite Not Available
Miami Jewish Health Systems
Miami, Florida 33137
United StatesSite Not Available
Brain Matters Research
Stuart, Florida 34997
United StatesSite Not Available
JEM Research Institute
Atlantis 4146372, Florida 4155751 33462
United StatesSite Not Available
Brain Matters Research
Delray Beach 4153132, Florida 4155751 33445
United StatesSite Not Available
Miami Jewish Health Systems
Miami 4164138, Florida 4155751 33137
United StatesSite Not Available
Brain Matters Research
Stuart 4174201, Florida 4155751 34997
United StatesSite Not Available
Augusta University Movement and Memory Disorders
Augusta, Georgia 30912
United StatesSite Not Available
Augusta University Movement and Memory Disorders
Augusta 4180531, Georgia 4197000 30912
United StatesSite Not Available
Velocity Clinical Research - Boise
Meridian, Idaho 83642
United StatesSite Not Available
Velocity Clinical Research - Boise
Meridian 5600685, Idaho 5596512 83642
United StatesSite Not Available
Northwestern University
Chicago, Illinois 606113010
United StatesSite Not Available
Northwestern University
Chicago 4887398, Illinois 4896861 606113010
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
Cypress Medical Research Center
Wichita, Kansas 67226
United StatesSite Not Available
Acadia Hospital
Bangor, Maine 04402
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
Donald S. Marks, MD, PC
Plymouth, Massachusetts 02360
United StatesActive - Recruiting
Headlands Eastern MA LLC
Plymouth, Massachusetts 02360
United StatesSite Not Available
Headlands Eastern MA LLC
Plymouth 4947597, Massachusetts 6254926 02360
United StatesSite Not Available
Bronson Lakeview Hospital
Kalamazoo, Michigan 49079
United StatesSite Not Available
Center for Advanced Medicine and Research
Saint Peters, Missouri 63303
United StatesSite Not Available
Princeton Medical Institute
Princeton, New Jersey 08540
United StatesSite Not Available
The Cognitive and Research Center of New Jersey
Springfield, New Jersey 07081
United StatesSite Not Available
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey 08755
United StatesSite Not Available
University of New Mexico
Albuquerque, New Mexico 87106
United StatesSite Not Available
University at Buffalo (UBMD)
Buffalo, New York 14203
United StatesSite Not Available
Velocity Clinical Research - Syracuse
East Syracuse, New York 13057
United StatesSite Not Available
Integrative Clinical Trials
New York, New York 11229
United StatesSite Not Available
Mount Sinai School of Medicine
New York, New York 100296552
United StatesSite Not Available
New York University Medical Center
New York, New York 100166055
United StatesSite Not Available
Integrative Clinical Trials
New York City, New York 11229
United StatesSite Not Available
Clarity Clinical Research
Syracuse, New York 13057
United StatesSite Not Available
SUNY Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available
University at Buffalo (UBMD)
Buffalo 5110629, New York 5128638 14203
United StatesSite Not Available
Velocity Clinical Research - Syracuse
East Syracuse 5116079, New York 5128638 13057
United StatesSite Not Available
Integrative Clinical Trials
New York 5128581, New York 5128638 11229
United StatesSite Not Available
Mount Sinai School of Medicine
New York 5128581, New York 5128638 100296552
United StatesSite Not Available
New York University Medical Center
New York 5128581, New York 5128638 100166055
United StatesSite Not Available
SUNY Upstate Medical University
Syracuse 5140405, New York 5128638 13210
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348 27157
United StatesSite Not Available
Rapid Medical Research
Cleveland, Ohio 44122
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Ohio State University
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
Central States Research (formerly Tulsa Clinical Research)
Tulsa, Oklahoma 74104
United StatesSite Not Available
Central States Research (formerly Tulsa Clinical Research)
Tulsa 4553433, Oklahoma 4544379 74104
United StatesSite Not Available
Providence Brain and Spine Institute
Portland, Oregon 97225
United StatesSite Not Available
Providence Brain and Spine Institute
Portland 5746545, Oregon 5744337 97225
United StatesSite Not Available
LeHigh Valley Hospital
Allentown, Pennsylvania 18105
United StatesSite Not Available
Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
LeHigh Valley Hospital
Allentown 5178127, Pennsylvania 6254927 18105
United StatesSite Not Available
Penn State Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033
United StatesSite Not Available
Ralph H. Johnson VA Health Care System
Charleston, South Carolina 294011113
United StatesSite Not Available
Ralph H. Johnson VA Health Care System
Charleston 4574324, South Carolina 4597040 294011113
United StatesSite Not Available
Neurology Clinic, P.C.
Cordova, Tennessee 38018
United StatesSite Not Available
Meharry Medical College
Nashville, Tennessee 37208
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United StatesSite Not Available
Neurology Clinic, P.C.
Cordova 4050552, Tennessee 4662168 38018
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37212
United StatesSite Not Available
University of Texas, Southwestern MC at Dallas
Dallas, Texas 75390
United StatesSite Not Available
Houston Methodist Neurological Institute
Houston, Texas 77030
United StatesSite Not Available
Glenn Biggs Institute at the University of Texas Health
San Antonio, Texas 78229
United StatesSite Not Available
Houston Methodist Neurological Institute
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Glenn Biggs Institute at the University of Texas Health
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84112
United StatesSite Not Available
UW Medicine Valley Medical Center
Renton, Washington 98055
United StatesSite Not Available
University of Washington / VA Puget Sound
Seattle, Washington 98195
United StatesSite Not Available
University of Washington Memory and Brain Wellness Center
Seattle, Washington 98195
United StatesSite Not Available
Kingfisher Cooperative, LLC
Spokane, Washington 99202
United StatesSite Not Available
University of Washington Memory and Brain Wellness Center
Seattle 5809844, Washington 5815135 98195
United StatesSite Not Available
Kingfisher Cooperative, LLC
Spokane 5811696, Washington 5815135 99202
United StatesSite Not Available
University of Wisconsin
Madison, Wisconsin 53706
United StatesSite Not Available
University of Wisconsin
Madison 5261457, Wisconsin 5279468 53706
United StatesSite Not Available

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