Effects of Liraglutide on Hippocampal Structure and Function in Aging Adults With Prediabetes

Completed · Phase 1 · Has a placebo group

Conditions studied: Insulin Resistance, Dementia

In brief

The purpose of this study is to evaluate the effects of liraglutide on the memory and attention of people with insulin resistance. Liraglutide is a medication that makes the body more sensitive to insulin, and therefore may allow it to manage sugar more effectively. The investigators are looking specifically at a region of the brain that is associated with memory and attention, called the hippocampus, in order to see whether treatment this treatment will change performance on memory and attention tasks. The investigators are also taking an MRI of the brain to see whether there are changes to the size and shape of the hippocampus after treatment. All subjects in this study will be 50-70 years old and have pre- diabetes. Half of all subjects will have a family history of dementia, while the other half will not.

Key facts

Study ID

NCT02140983

Run by

Stanford University

People needed

41

Starts

2013-08-01

Expected to finish

2017-02-01

Last updated by the study team

2018-01-25

Who can join

Age: 50 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects will be men and women between the ages of 50 and 70 yrs of age, with a BMI of 27 to 37 kg/m2 and at least 12 yrs of education.
• All subjects will be medically stable (i.e. no uncontrolled or poorly controlled medical illnesses), cognitively-intact as defined by Mini Mental Status Exam (MMSE) score of > 27, and will have adequate visual and auditory acuity to allow for cognitive testing.
• Metabolic function will be determined as impaired fasting glucose 100-125 mg/dL and/or impaired 2-hr glucose concentration 140-199 and <200mg/dL on 75-g oral glucose challenge.
• Also, half of all subjects will have a family history of dementia.

You may not qualify if…

• Diagnosis of possible or probable AD, MCI, or any other dementia; evidence of cognitive decline by MMSE score of <27 or self-reported significant decline in memory within the past year (per the Memory Function Questionnaire) (MFQ)
• History of Type I or Type II diabetes, or fasting plasma glucose > 126 mg/dL
• History of significant CVD or myocardial infarction; unstable cerebrovascular or pulmonary disease, gallstones, pancreatitis or cancer, multiple endocrine neoplasia (MEN) untreated hypothyroidism, unstable or untreated hypertension, anemia as determined by hematocrit < 30%
• Abnormal renal clearance as determined by the serum creatinine ³ 1.5 mg/d, hepatic dysfunction as determined by ALT > 2 times the upper limit of normal
• Presence of medications known to affect insulin action or insulin secretion
• Premature birth (which may affect MRI findings), history of neurological disorder (ischemic attacks, carotid bruits, or lacunes upon MRI scan), or evidence of neurologic or other physical illness that could produce cognitive deterioration; use of any drug that may significantly affect the OGTT results or cognitive testing results (specifically: cs)
• Drug or alcohol abuse or dependence within the past 6 months, positive urine toxicology screen for illicit substances at eligibility screening, history of mental illness, with the exception of past mood disorder, or evidence of acute depression as determined by a 17-item Hamilton Depression Rating Scale (HDRS-17) score of 8 or more.
• Participants with history of mood disorder must be in remission for at least 6 months prior to study entry.

Where it is running

• Stanford Department of Psychiatry — Stanford, California, United States

Full record on ClinicalTrials.gov

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