TerminatedPhase 2Results posted

Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease

A Phase II, Single Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and the Therapeutic Effectiveness of Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease

Lead sponsor

HealthPartners Institute

Asset

Insulin glulisine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•MoCA 18-27

Primary endpoints

•ADAS-Cog•Clinical Dementia Rating-Sum of Boxes (CDR-SB)•Functional Performance

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 IDIN-INSUL-MCI-AD

NCT IDNCT02503501

Timeline

Milestones

Study first posted2015-07-21estimated

Study start2015-09-28actual

Primary completion2019-02-11actual

Study completion2019-02-15actual

Last update posted2020-04-09actual

Results first posted2020-04-09actual

Assets

Drug assets

Insulin glulisine

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Subject is/has

•clinical and research diagnosis of amnestic-MCI OR probable mild AD in accordance with National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

•Montreal Cognitive Assessment (MoCA) score 18-27

•Hachinski Ischemia Score <4

•50-90 years of age

•Females at least 2 years post-menopausal or surgically sterile

•Proficiency in speaking, reading and understanding English

•Dedicated family member /caregiver, who will be able to attend all visits and report on subject's status

•(and family member/caregiver) provided fully informed written consent prior to participation. In the event that subject is legally unable to provide informed written consent due to deterioration in cognitive abilities, fully informed written consent must be provided by a legally authorized representative

•If AD, a brain computed tomography (CT) or magnetic resonance imaging (MRI) in the initial diagnostic workup or subsequent care that is compatible with the diagnosis of probable AD

Exclusion criteria

Subject has/have/is

•medical history and/or clinically determined evidence of other central nervous system (CNS) disorders including, but not limited to brain tumor, active subdural hematoma, seizure disorder, multiple sclerosis, dementia with Lewy bodies, vascular dementia, corticobasal syndrome, progressive supranuclear palsy, Parkinson's disease, multiple system atrophy, frontotemporal dementia, normal pressure hydrocephalus, Huntington's disease, or Jakob-Creutzfeldt disease presenting as dementia

•medical history and/or clinically determined disorders: current B12 deficiency, chronic sinusitis, any untreated thyroid disease, significant head trauma and history of difficulty with smell and/or taste prior to AD diagnosis

•history of any of the following: moderate to severe pulmonary disease, poorly controlled congestive heart failure, significant cardiovascular and/or cerebrovascular events within previous 6 months, condition known to affect absorption, distribution, metabolism, or excretion of drugs such as any hepatic, renal or gastrointestinal disease or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator

•previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies

•history of any psychiatric illness, with the exception of major depressive and anxiety disorder (according to Diagnostic and Statistical Manual of Mental Disorders, version 5, Text Revision (DSM-IV TR)) currently in remission or stable with treatment for > 2 yrs, or any other psychiatric condition that inclusion would pose a safety risk to the subject as determined by investigator

•currently taking any medications, herbals and food supplements that are medically/clinically contraindicated as determined by investigator in order to comply with procedural testing of cognitive function as well as ensure study safety. See list of prohibited medications and compounds

•undergone a recent change (<1mo) in their prescribed acetylcholinesterase inhibitor (e.g. donepezil, rivastigmine, galantamine) or memantine.

•undergone a recent change (<1mo) in their selective serotonin re-uptake inhibitor (SSRI) or anti-depressant medication

•current or recent drug or alcohol abuse or dependence as defined by DSM-IV TR

•laboratory results that are medically relevant, in which inclusion would pose a safety risk to the subject as determined by investigator

•participated in any other research study at least 3 mos prior to this study

•an insulin allergy

Endpoints (6)

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

Function / daily living

Global cognition

4 endpoints

Primary/protocol endpoint

Change in Cognition as Measured by the Alzheimer's Disease Assessment Scale - Cognitive 13 (ADAS-Cog 13)

Time frame:Baseline and 6 months

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

Change in Functional Performance as Measured by the Clinical Dementia Rating (CDR) Scale

Time frame:Baseline and 6 months

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Primary/registry result

Change in Cognition as Measured by the Alzheimer's Disease Assessment Scale - Cognitive 13 (ADAS-Cog 13)

Time frame:Baseline and 6 months

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Insulin Glulisinen=16 Participants	1.56	4.2
Placebon=12 Participants	0.81	4.8

Primary/registry result

Change in Functional Performance as Measured by the Clinical Dementia Rating (CDR) Scale

Time frame:Baseline and 6 months

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Insulin Glulisinen=16 Participants	0.53	.9
Placebon=12 Participants	-0.08	1.5

Function / daily living

2 endpoints

Primary/protocol endpoint

Change in Functional Performance as Measured by the Functional Activities Questionnaire (FAQ)

Time frame:Baseline and 6 months

change from baseline, improvement

Primary/registry result

Change in Functional Performance as Measured by the Functional Activities Questionnaire (FAQ)

Time frame:Baseline and 6 months

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Insulin Glulisinen=16 Participants	2.5	3.2
Placebon=12 Participants	0.92	3.4

Publications (1)

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

Rosenbloom M, Barclay TR, Kashyap B, Hage L, O'Keefe LR, Svitak A, Pyle M, Frey W, Hanson LR. A Phase II, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Therapeutic Efficacy of Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease. Drugs Aging. 2021 May;38(5):407-415. doi: 10.1007/s40266-021-00845-7. Epub 2021 Mar 15.
PMID33719017via DERIVED

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.