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MIND

CompletedPhase 2

Memory Improvement Through Nicotine Dosing (MIND) Study

Long-Term Nicotine Treatment of Mild Cognitive Impairment

Asset

Nicotine

Listed sites

36

Recruiting sites

-

Enrollment

348

actual

Study population

MCI / preclinical Alzheimer’s

Key I/E criteria

Alzheimer's diseaseCDR global ≥0.5Study partner/caregiver requiredMRI 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

Secondary ID131918Food and Drug Administration (FDA)
Org study IDATRI-002-NIC
NCT IDNCT02720445
NihR01AG047992

Timeline

Milestones

Study first posted2016-03-25estimated
Study start2017-01-13actual
Primary completion2025-08-25actual
Study completion2025-09-16actual
Last update posted2025-10-01actual

Assets

Drug assets

Study populations

Who this study enrolls

MCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

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:

-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 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:

-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.

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

Memory
2
Behavior / neuropsychiatric
2
Global cognition
1
Function / daily living
1
Neuroimaging
1
Fluid / digital biomarkers
1
Other clinical outcomes
1
Other (unclassified)
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Change 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 endpoints
Primary/protocol endpoint

Cogstate Battery International Shopping List Test - Total Immediate Recall (ISLT-TIR)

Time frame:2 years

descriptive

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Change 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 endpoints
Secondary/protocol endpoint

Change in Baseline in Geriatric Depression Scale (GDS) to Month 25

Time frame:2 years

change from baseline, improvement

Secondary/protocol endpoint

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 endpoint
Other/protocol endpoint

Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) to Month 25

Time frame:2 years

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint
Other/protocol endpoint

Change from Baseline in Cerebral Spinal Fluid (CSF) Biomarkers to Month 25

Time frame:2 years

change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Change 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 endpoint
Secondary/protocol endpoint/low confidence

Change 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.