Clinical trial NCT01145482: Mechanisms of Insulin Facilitation of Memory
Official title: Mechanisms of Insulin Facilitation of Memory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Disorders
Keywords: Memory Disorders
Alzheimer's Disease
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2010-06-16
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: The specific aims of this project will be accomplished through a cross sectional repeated measures design in which 15 participants with mild AD or amnestic MCI will undergo assessments of brain structure and function 15 minutes after a single dose of insulin (20 IU) or placebo. Insulin and placebo conditions will be counterbalanced across participants.

Intranasal insulin or placebo administration: Saline and insulin (NovoLog) will be ordered though the UT Student Health Services Pharmacy (Sharon Roberson, Chief Pharmacist) and stored at 4°C, according to standard pharmacy protocols. Three ml doses of saline or insulin will be packaged in nasal spray bottles (e.g., Spectrum Pharmacy Products bottles 969-17404P and actuators 551-24362P) designed to deliver 100μL dose with each spray. A total volume of 200μL will be delivered during each administration (one 100μL dose in each nostril).

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

Primary outcomes:
measure: Cerebral Glutamate Concentration
timeFrame: 15 minutes post insulin or placebo administration
Secondary outcomes:
measure: Memory
timeFrame: 15 minutes post insulin or placebo administration
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Andreana P Haley, PhD
role: PRINCIPAL_INVESTIGATOR
References: