Mild Cognitive ImpairmentPhase 2MINDNCT02720445
Memory Improvement Through Nicotine Dosing (MIND) Study
A Phase 2 study testing Nicotine Transdermal Patch in people with Mild Cognitive Impairment, run by University of Southern California at 36 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Nicotine Transdermal Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 36 sitesUnited States
- Study dates
- 22 Feb 2017to 16 Sep 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have a subjective memory concern as reported by participant, study partner, or clinician
- 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
- Mini-Mental State Exam score between 24 and 30, inclusive
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- 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 a diagnosis of Alzheimer's disease dementia cannot be made by the site physician at the 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 prior to 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. an average of 10 hours per week or more), and can accompany the participant to most visits 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 with the study
- Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile)
- Completed six grades of education or has a good work history
- Fluent in English or Spanish
Who cannot join
- 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'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.
- 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
- History of schizophrenia (DSM V criteria)
- History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria)
- 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.
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- 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
- 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.
- 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 is longer, prior to screening.
- For CSF sub-study participants, a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT (partial thromboplastin time) at screening
- For MRI sub-study participants, contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker.
- Patients whom the Site PI deems to be otherwise ineligible.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
LeHigh Valley Hospital
Allentown, Pennsylvania, 18105
JEM Research Institute
Atlantis, Florida, 33462
Augusta University Movement and Memory Disorders
Augusta, Georgia, 30912
University at Buffalo (UBMD)
Buffalo, New York, 14203
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, 294011113
Northwestern University
Chicago, Illinois, 606113010
Ohio State University
Columbus, Ohio, 43210
Neurology Clinic, P.C.
Cordova, Tennessee, 38018
Nuvance Health Medical Practice Ct, Inc.; Associated Neurologists, PC
Danbury, Connecticut, 06810
Brain Matters Research
Delray Beach, Florida, 33445
USC Rancho Los Amigos
Downey, California, 90242
Velocity Clinical Research - Syracuse
East Syracuse, New York, 13057
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Houston Methodist Neurological Institute
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Wisconsin
Madison, Wisconsin, 53706
Velocity Clinical Research - Boise
Meridian, Idaho, 83642
Miami Jewish Health Systems
Miami, Florida, 33137
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
New York University Medical Center
New York, New York, 100166055
Mount Sinai School of Medicine
New York, New York, 100296552
Integrative Clinical Trials
New York, New York, 11229
Central Arkansas Veterans Healthcare System
North Little Rock, Arkansas, 72205
Headlands Eastern MA LLC
Plymouth, Massachusetts, 02360
Providence Brain and Spine Institute
Portland, Oregon, 97225
Glenn Biggs Institute at the University of Texas Health
San Antonio, Texas, 78229
Sharp Neurocognitive Research Center
San Diego, California, 92123
Syrentis Clinical Research
Santa Ana, California, 92705
Perseverance Research Center
Scottsdale, Arizona, 85254
University of Washington Memory and Brain Wellness Center
Seattle, Washington, 98195
Kingfisher Cooperative, LLC
Spokane, Washington, 99202
Brain Matters Research
Stuart, Florida, 34997
SUNY Upstate Medical University
Syracuse, New York, 13210
Central States Research (formerly Tulsa Clinical Research)
Tulsa, Oklahoma, 74104
Georgetown University
Washington D.C., District of Columbia, 200072145
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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 380 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Nicotine Transdermal Patch, Placebo Patch
- Keywords
- Alzheimer's Disease, Nicotine, Transdermal Patch
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Transdermal PatchDrug
21mg Nicotine transdermal patches worn during waking hours. Active dose will titrate up from 3.5mg to 21mg in the first 5 weeks of treatment, remain at 21mg up to month 24, and then taper down for three weeks.
Placebo PatchDrug
Matching placebo patches worn during waking hours.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Transdermal Patch | Experimental | Participants will wear nicotine transdermal patches during waking hours. Active dose will titrate up from 3.5mg to 21mg in the first 5 weeks of treatment, remain at 21mg up to 24 month, and then taper down for 3 weeks. Receives: Drug: Nicotine Transdermal Patch |
| Placebo Patch | Placebo comparator | Participants will wear matching placebo patches during waking hours. Receives: Drug: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cogstate Battery International Shopping List Test - Total Immediate Recall (ISLT-TIR)
The ISLT - TIR represents the number of correct responses made when remembering the twelve word shopping list on three consecutive trials. The unit of the variable is correct responses count and higher score is better performance. Scores range from 0 to 36.
Measured: From Baseline to month 24
Secondary outcomes (11)
Change From Baseline in Mild Cognitive Impairment - Clinical Global Impression of Change (MCI-CGIC) to Month 24
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.
Measured: From Baseline to month 24
International Shopping List Test - Delayed Recall (ISRL)
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.
Measured: From Baseline to month 24
Identification Task
The IDN evaluates attention and is assessed in speed of performance. Lower score is better performance.
Measured: From Baseline to month 24
One Card Learning Task (OCL)
The OCL evaluates visual learning and is assessed in accuracy of performance; performance; arcsine square root proportion correct. Higher score is better performance. Ranges from 0 to 1.5708
Measured: From Baseline to month 24
Detection Task
The DET evaluates Psychomotor Function and is assessed in speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score is better performance, ranges from 2.001 to 6.
Measured: From Baseline to month 24
One Back Task (ONB)
The ONB evaluates working memory and is assessed in speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score is better performance, ranges from ranges from 2.001 to 6.
Measured: From Baseline to month 24
NYU Immediate Recall (NYU-Immediate)
The NYU-Immediate recall evaluates immediate verbal recall. Higher is better performance
Measured: From Baseline to month 24
NYU Delayed Recall (NYU-DELAY)
The NY-DELAY evaluates delayed verbal recall. Higher is better performance
Measured: From Baseline to month 24
Clinical Dementia Rating Scale (CDR) - Sum of Boxes (SOB)
The is a clinical scale that rates the severity of dementia as absent, questionable, mild, moderate, or severe.
Measured: From Baseline to month 24
Geriatric Depression Scale (GDS)
The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".
Measured: Month 24
Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
This scale is an inventory developed to assess functional performance in participantss with Alzheimer's disease.
Measured: From Baseline to month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start22 Feb 2017
- Primary completion25 Aug 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Vanderbilt University, Alzheimer's Therapeutic Research Institute
- Responsible party
- Principal investigator, Paul S. Aisen, University of Southern California
- Investigators
- Paul Aisen, MD, Study director, USC Alzheimer's Therapeutic Research Institute (ATRI)Paul Newhouse, MD, Study director, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720445
- Sponsor's protocol ID
- ATRI-002-NIC
- Other IDs
- R01AG047992, 131918
- Acronym
- MIND
- Status last verified
- Sep 2026
- First submitted
- 22 Mar 2016
- Last updated
- 17 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Newhouse PA, Potter A, Corwin J, Lenox R. Age-related effects of the nicotinic antagonist mecamylamine on cognition and behavior. Neuropsychopharmacology. 1994 Apr;10(2):93-107. doi: 10.1038/npp.1994.11.
PubMed 8024677Newhouse P, Kellar K, Aisen P, White H, Wesnes K, Coderre E, Pfaff A, Wilkins H, Howard D, Levin ED. Nicotine treatment of mild cognitive impairment: a 6-month double-blind pilot clinical trial. Neurology. 2012 Jan 10;78(2):91-101. doi: 10.1212/WNL.0b013e31823efcbb.
PubMed 22232050Dumas J, Hancur-Bucci C, Naylor M, Sites C, Newhouse P. Estrogen treatment effects on anticholinergic-induced cognitive dysfunction in normal postmenopausal women. Neuropsychopharmacology. 2006 Sep;31(9):2065-78. doi: 10.1038/sj.npp.1301042. Epub 2006 Feb 15.
PubMed 16482084Newhouse PA, Dumas J, Hancur-Bucci C, Naylor M, Sites CK, Benkelfat C, Young SN. Estrogen administration negatively alters mood following monoaminergic depletion and psychosocial stress in postmenopausal women. Neuropsychopharmacology. 2008 Jun;33(7):1514-27. doi: 10.1038/sj.npp.1301530. Epub 2007 Aug 15.
PubMed 17700646Newhouse PA, Sunderland T, Tariot PN, Blumhardt CL, Weingartner H, Mellow A, Murphy DL. Intravenous nicotine in Alzheimer's disease: a pilot study. Psychopharmacology (Berl). 1988;95(2):171-5. doi: 10.1007/BF00174504.
PubMed 3137593Joe E, Ringman JM. Cognitive symptoms of Alzheimer's disease: clinical management and prevention. BMJ. 2019 Dec 6;367:l6217. doi: 10.1136/bmj.l6217.
PubMed 31810978
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Nicotine Treatment of Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02720445
- Acronym / sponsor ID
- MIND / ATRI-002-NIC
- Conditions
- Mild Cognitive Impairment
- Keywords
- Alzheimer's Disease, Nicotine, Transdermal Patch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Vanderbilt University, Alzheimer's Therapeutic Research Institute
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Posted 17 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 380 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Transdermal Patch | Experimental | Drug: Nicotine Transdermal PatchParticipants will wear nicotine transdermal patches during waking hours. Active dose will titrate up from 3.5mg to 21mg in the first 5 weeks of treatment, remain at 21mg up to 24 month, and then taper down for 3 weeks. |
| Placebo Patch | Placebo comparator | Drug: Placebo PatchParticipants will wear matching placebo patches during waking hours. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participant must have a subjective memory concern as reported by participant, study partner, or clinician
- 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:
- 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 a diagnosis of Alzheimer's disease dementia cannot be made by the site physician at the time of the screening visit
Key exclusion criteria (16 listed)
- 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'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.
- 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
- History of schizophrenia (DSM V criteria)
- History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Transdermal Patch21mg Nicotine transdermal patches worn during waking hours. Active dose will titrate up from 3.5mg to 21mg in the first 5 weeks of treatment, remain at 21mg up to month 24, and then taper down for three weeks. | Drug | Nicotine Transdermal Patch |
| Placebo PatchMatching placebo patches worn during waking hours. | Drug | Placebo Patch |
Primary outcome
Cogstate Battery International Shopping List Test - Total Immediate Recall (ISLT-TIR)
Time frame: From Baseline to month 24
The ISLT - TIR represents the number of correct responses made when remembering the twelve word shopping list on three consecutive trials. The unit of the variable is correct responses count and higher score is better performance. Scores range from 0 to 36.
11 secondary outcomes
Change From Baseline in Mild Cognitive Impairment - Clinical Global Impression of Change (MCI-CGIC) to Month 24
Time frame: From Baseline to month 24
International Shopping List Test - Delayed Recall (ISRL)
Time frame: From Baseline to month 24
Identification Task
Time frame: From Baseline to month 24
One Card Learning Task (OCL)
Time frame: From Baseline to month 24
Detection Task
Time frame: From Baseline to month 24
One Back Task (ONB)
Time frame: From Baseline to month 24
NYU Immediate Recall (NYU-Immediate)
Time frame: From Baseline to month 24
NYU Delayed Recall (NYU-DELAY)
Time frame: From Baseline to month 24
Clinical Dementia Rating Scale (CDR) - Sum of Boxes (SOB)
Time frame: From Baseline to month 24
Geriatric Depression Scale (GDS)
Time frame: Month 24
Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
Time frame: From Baseline to month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8024677Newhouse PA, Potter A, Corwin J, Lenox R. Age-related effects of the nicotinic antagonist mecamylamine on cognition and behavior. Neuropsychopharmacology. 1994 Apr;10(2):93-107. doi: 10.1038/npp.1994.11.
- Background: PubMed 22232050Newhouse P, Kellar K, Aisen P, White H, Wesnes K, Coderre E, Pfaff A, Wilkins H, Howard D, Levin ED. Nicotine treatment of mild cognitive impairment: a 6-month double-blind pilot clinical trial. Neurology. 2012 Jan 10;78(2):91-101. doi: 10.1212/WNL.0b013e31823efcbb.
- Background: PubMed 16482084Dumas J, Hancur-Bucci C, Naylor M, Sites C, Newhouse P. Estrogen treatment effects on anticholinergic-induced cognitive dysfunction in normal postmenopausal women. Neuropsychopharmacology. 2006 Sep;31(9):2065-78. doi: 10.1038/sj.npp.1301042. Epub 2006 Feb 15.
- Background: PubMed 17700646Newhouse PA, Dumas J, Hancur-Bucci C, Naylor M, Sites CK, Benkelfat C, Young SN. Estrogen administration negatively alters mood following monoaminergic depletion and psychosocial stress in postmenopausal women. Neuropsychopharmacology. 2008 Jun;33(7):1514-27. doi: 10.1038/sj.npp.1301530. Epub 2007 Aug 15.
- Background: PubMed 3137593Newhouse PA, Sunderland T, Tariot PN, Blumhardt CL, Weingartner H, Mellow A, Murphy DL. Intravenous nicotine in Alzheimer's disease: a pilot study. Psychopharmacology (Berl). 1988;95(2):171-5. doi: 10.1007/BF00174504.
- Derived from this study: PubMed 31810978Joe E, Ringman JM. Cognitive symptoms of Alzheimer's disease: clinical management and prevention. BMJ. 2019 Dec 6;367:l6217. doi: 10.1136/bmj.l6217.
- Alzheimer's Therapeutic Research Institute (ATRI). ATRI is the Coordinating Center for the MIND study.Link provided by the sponsor.
- MIND study public websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Aisen, MD study director
USC Alzheimer's Therapeutic Research Institute (ATRI)
Paul Newhouse, MD study director
Vanderbilt University
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotine Transdermal Patch in people with Mild Cognitive Impairment, run by University of Southern California at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cogstate Battery International Shopping List Test - Total Immediate Recall (ISLT-TIR) (time frame: From Baseline to month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02720445, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.