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MIND
CompletedPhase 2Memory Improvement Through Nicotine Dosing (MIND) Study
Long-Term Nicotine Treatment of Mild Cognitive Impairment
Lead sponsor
Asset
Nicotine
Listed sites
36
Recruiting sites
-
Enrollment
348
actual
Study population
MCI / preclinical Alzheimer’s
Key I/E criteria
•Alzheimer's disease•CDR global ≥0.5•Study partner/caregiver required•MRI contraindications excluded
Primary endpoint
•Cogstate Battery International Shopping List Test - Total Immediate Recall
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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:
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. Fluent in English or Spanish
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:
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.
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
1 endpointChange from Baseline in Clinical Dementia Rating Scale (CDR) - Sum of Boxes (SOB) to Month 25
Time frame:2 years
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
change from baseline, improvement
Memory
2 endpointsCogstate Battery International Shopping List Test - Total Immediate Recall (ISLT-TIR)
Time frame:2 years
descriptive
Change in Baseline in New York University (NYU) Paragraph Recall to Month 25
Time frame:2 years
change from baseline, improvement
Function / daily living
1 endpointChange in Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) to Month 25
Time frame:2 years
ADCS-Activities of Daily Living (ADCS-ADL)
change from baseline, improvement
Behavior / neuropsychiatric
2 endpointsChange in Baseline in Geriatric Depression Scale (GDS) to Month 25
Time frame:2 years
change from baseline, improvement
Change from Baseline in Older Adult Self Report (OASR) / Older Adult Behavior Checklist (OABCL) to Month 25
Time frame:2 years
change from baseline, improvement
Neuroimaging
1 endpointChange from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) to Month 25
Time frame:2 years
change from baseline, improvement
Fluid / digital biomarkers
1 endpointChange from Baseline in Cerebral Spinal Fluid (CSF) Biomarkers to Month 25
Time frame:2 years
change from baseline, improvement
Other clinical outcomes
1 endpointChange from Baseline in Mild Cognitive Impairment - Clinical Global Impression of Change (MCI-CGIC) to Month 25
Time frame:2 years
change from baseline, improvement
Other (unclassified)
1 endpointChange from Baseline in Cogstate Brief Battery (CBB) to Month 25
Time frame:2 years
change from baseline, improvement
Publications (6)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID17700646via BACKGROUND
- PMID16482084via BACKGROUND
- PMID31810978via DERIVED
- PMID8024677via BACKGROUND
- PMID3137593via BACKGROUND
- PMID22232050via BACKGROUND
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.