WithdrawnPhase NA

Efficacy of Pulsatile IV Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease

Evaluating the Efficacy of Controlled Pulsatile Intravenous Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease- A Pilot Study

Lead sponsor

Louisiana State University Health Sciences Center Shreveport

Asset

Insulin LISPRO

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•MMSE 15•Study partner/caregiver required

Primary endpoints

•Cerebral glucose metabolism•Mini-Mental State Examination (MMSE)

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 IDH12-166

NCT IDNCT01636596

Timeline

Milestones

Study first posted2012-07-10estimated

Study start2013-09 (month precision)

Last update posted2014-03-13estimated

Primary completion2015-01estimated (month precision)

Study completion2015-01estimated (month precision)

Assets

Drug assets

Insulin LISPRO

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Between 50 and 95 years of age

•Have a clinical diagnosis of Mild Cognitive Impairment or Alzheimer's Disease

•Have a Folstein Mini-Mental State Exam (MMSE) score of 15 or greater

•Be physically able to take part in the study

•Females will not be of child-bearing potential (one year postmenopausal, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

•Be able to give informed consent for study procedures; if incapable of giving informed consent, the subject's designated decision maker may consent on their behalf but the subject must still be able to confirm assent

•Have a "study partner" willing to accompany them to all study visits

Exclusion criteria

•Have a major or unstable medical illness such that, in the PI's clinical judgment, will prohibit or interfere with involvement in this research protocol, including diabetes

•Have current substance or alcohol dependence, or abuse within the last eight weeks

•Have the ApoE4 homozygous genotype

Endpoints (4)

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

Neuroimaging

Caregiver / quality of life

Other (unclassified)

Global cognition

1 endpoint

Primary/protocol endpoint

cognition

Time frame:30 weeks

Mini-Mental State Examination (MMSE)

descriptive

Neuroimaging

1 endpoint

Primary/protocol endpoint

cerebral glucose metabolism

Time frame:25 weeks

descriptive

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

general clinical improvement

Time frame:30 weeks

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

basal metabolism

Time frame:30 weeks

descriptive

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.