N/A Completed N=12 Randomized Quadruple-blind Basic Science

Mechanisms of Insulin Facilitation of Memory

Memory Disorders

Source: ClinicalTrials.gov NCT01145482 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcomePrimary: Cerebral Glutamate Concentration — 1.34; 1.34 ratio

Summary

The study described in the present application will test the hypothesis that insulin mediated facilitation of memory in Alzheimer's disease (AD) is achieved through enhanced glutamatergic neurotransmission due to improvements in cerebral glucose metabolism. The effect of a single dose of intranasal insulin on memory and cerebral glutamate concentrations in adults with mild AD or amnestic mild cognitive impairment (aMCI), the presumed prodromal phase of AD will be studied. Successful completion of this study may set the stage for a larger-scale treatment trial of intranasal insulin for adults with memory disorders. However, the use of insulin in this manner at this point in time is purely experimental.

Outcome Measures

Outcome	Result	p-value
PRIMARY Cerebral Glutamate Concentration	1.34; 1.34	—
SECONDARY Memory	6.73; 5.36	—

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of probable AD
Age over 21
Clinical Dementia Rating of 0.5 or 1.0
Mini Mental State Exam Score>15

Exclusion Criteria

preexisting diabetes
significant neurological disease that might affect cognition, other than AD, including stroke, Parkinson's disease, multiple sclerosis
severe head injury with loss of consciousness > 30 minutes or with permanent neurological sequelae
significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease
current use of anti-psychotic or anti-convulsant medications
current or previous use of hypoglycemic agents or insulin
MRI contraindications
claustrophobia
pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01145482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.