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SL120

CompletedPhase 2Results posted

Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120)

Assets

Insulin / Insulin detemir

Listed sites

2

Recruiting sites

-

Enrollment

37

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Verbal Memory Composite

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

Org study IDIRB00023230
NCT IDNCT01595646
Other grantZEN-10-173646USAlzheimer's Association

Timeline

Milestones

Study start2011-11actual (month precision)
Study first posted2012-05-10estimated
Primary completion2015-03-12actual
Study completion2015-03-12actual
Results first posted2018-02-01actual
Last update posted2020-11-17actual

Assets

Drug assets

InsulinInsulin detemir

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
Maximum age89 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age 50-89
•Diagnosed with mild cognitive impairment, or mild/moderate AD

Exclusion criteria

•Excessively high or low blood pressure, heart rate
•Pre-existing diabetes not controlled by exercise/diet
•Previous/current use of insulin
•Significant elevations in lipids, liver enzymes
•Menstrual period within the last 12 months
•Significant neurological or medical disorder (other than AD)
•Significant use of nasal decongestants
•Current use of anti-psychotic, anti-convulsive, anxiolytic, glucocorticoids, or sedative medications

Endpoints (18)

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
6
Amyloid biomarkers
6
Global cognition
2
Neuroimaging
2
Other (unclassified)
2

Global cognition

2 endpoints
Secondary/protocol endpoint

The Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI Revision

Time frame:Baseline, Month 2 and Month 4

ADAS-Cog

descriptive

Secondary/registry result

The Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI Revision

Time frame:Baseline, Month 2 and Month 4

ADAS-Cog

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
SalineBaselinen=12 Participants2011.7
Month 2n=12 Participants18.511.8
Month 4n=12 Participants20.413.7
Insulin DetemirBaselinen=12 Participants21.613.7
Month 2n=12 Participants23.417.1
Month 4n=12 Participants19.512.9
InsulinBaselinen=12 Participants19.812.8
Month 2n=12 Participants21.813.6
Month 4n=12 Participants22.615.8

Memory

6 endpoints
Primary/protocol endpoint

Verbal Memory Composite

Time frame:Change from Baseline in Verbal Memory at 16 weeks

event count, event

Primary/registry result

Verbal Memory Composite

Time frame:Change from Baseline in Verbal Memory at 16 weeks

event count, event

Posted result

GroupValue (mean), Change in Z score memory compositeStandard error
Salinen=12 Participants-.31247583.23
Insulin Detemirn=12 Participants.33390008.23
Insulinn=12 Participants-.05181561.22
Secondary/protocol endpoint

Functional Ability

Time frame:baseline, month 2, and month 4

descriptive

Secondary/registry result

Functional Ability

Time frame:baseline, month 2, and month 4

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
SalineBaselinen=12 Participants7.36.9
month 2n=12 Participants76.7
month 4n=12 Participants6.97.1
Insulin DetemirBaselinen=12 Participants8.76.7
month 2n=12 Participants9.77.3
month 4n=12 Participants9.17.5
InsulinBaselinen=12 Participants7.76.8
month 2n=12 Participants9.77.4
month 4n=12 Participants10.69.4
Other/protocol endpoint

Executive Function Composite

Time frame:Change from Baseline in Executive Functioning at 16 Weeks

descriptive

Other_pre_specified/registry result

Executive Function Composite

Time frame:Change from Baseline in Executive Functioning at 16 Weeks

descriptive

Amyloid biomarkers

6 endpoints
Secondary/protocol endpoint

Cerebral Spinal Fluid (CSF) Biomarkers of AD

Time frame:Change from Baseline in CSF Biomarkers at 16 Weeks

descriptive

Secondary/protocol endpoint

Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio

Time frame:Change from Baseline in CSF Biomarkers at 16 Weeks

ratio, descriptive

Secondary/registry result

Cerebral Spinal Fluid (CSF) Biomarkers of AD

Time frame:Change from Baseline in CSF Biomarkers at 16 Weeks

descriptive

Posted result

GroupValue (mean), pg/mLStandard deviation
SalineAbeta42 Pren=12 Participants331.5148.4
Abeta 42 Postn=12 Participants384212
Tau Pren=12 Participants109.727
Tau Postn=12 Participants117.136.8
Tau-P181 Pren=12 Participants65.133.1
Tau-P181 Postn=12 Participants72.1725.3
Insulin DetemirAbeta42 Pren=12 Participants408.5196.9
Abeta 42 Postn=12 Participants381.8227.8
Tau Pren=12 Participants118.349.1
Tau Postn=12 Participants107.656
Tau-P181 Pren=12 Participants63.928
Tau-P181 Postn=12 Participants64.119.8
InsulinAbeta42 Pren=12 Participants305.586.1
Abeta 42 Postn=12 Participants32592.1
Tau Pren=12 Participants132.371
Tau Postn=12 Participants152.2106.7
Tau-P181 Pren=12 Participants7428.9
Tau-P181 Postn=12 Participants68.539.7
Secondary/registry result

Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio

Time frame:Change from Baseline in CSF Biomarkers at 16 Weeks

ratio, descriptive

Posted result

GroupValue (mean), ratioStandard deviation
SalineTTau-P181/Abeta42 ratio Pren=12 Participants.2719
Tau-P181/Abeta42 ratio Postn=12 Participants.30.21
Insulin DetemirTTau-P181/Abeta42 ratio Pren=12 Participants.23.22
Tau-P181/Abeta42 ratio Postn=12 Participants.23.16
InsulinTTau-P181/Abeta42 ratio Pren=12 Participants.27.14
Tau-P181/Abeta42 ratio Postn=12 Participants.23.13
Other/protocol endpoint

Plasma Biomarkers of AD

Time frame:Change from Baseline in Plasma Biomarkers at 16 Weeks

descriptive

Other_pre_specified/registry result

Plasma Biomarkers of AD

Time frame:Change from Baseline in Plasma Biomarkers at 16 Weeks

descriptive

Neuroimaging

2 endpoints
Other/protocol endpoint

Cerebral Blood Flow

Time frame:Change from Baseline in Cerebral Blood Flow at 16 Weeks

descriptive

Other_pre_specified/registry result

Cerebral Blood Flow

Time frame:Change from Baseline in Cerebral Blood Flow at 16 Weeks

descriptive

Other (unclassified)

2 endpoints
Other/protocol endpoint/low confidence

Glucose Tolerance

Time frame:Change from Baseline in Glucose Tolerance at 16 Weeks

descriptive

Other_pre_specified/registry result/low confidence

Glucose Tolerance

Time frame:Change from Baseline in Glucose Tolerance at 16 Weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.