Liraglutide Effects on Memory in Healthy Subjects

Study Overview
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Brief Summary
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This study examines the hypothesis, that subcutaneous administration of liraglutide, an analogue of the incretin glucagon-like peptide 1, over 5 weeks improves memory functions in healthy humans.

Official Title
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Liraglutide Effects on Memory in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: liraglutide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male sex Age 18-35 years Body mass index between 19 and 25 kg/m2 Non-smoker Exclusion Criteria: Receipt of any drug within 4 weeks prior to this trial Any known acute or chronic disease of the brain, heart, lung, kidney,liver, pancreas or gastrointestinal tract, any metabolic, endocrine or psychiatric disease. Brady- and Tachycardia, i.e. heart rate < 50 and > 90 beats per minute. Hypertension (systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 mmHg). Hyperlipidemia (cholesterol, LDL, triglyceride > two times the upper reference limit based on analysis from the central laboratory) Impaired hepatic function measured as alanine aminotransferase (ALAT) > two times the upper reference limit based on analysis from the central laboratory Impaired renal function measured as creatinine > 120 µmol/l based on analysis from the central laboratory Family history of diabetes History of any eating disorder Known or suspected allergy to trial products History of drug or alcohol abuse within the last five years prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide<br>See Intervention | Drug: liraglutide<br>* Subcutaneous self-administration of liraglutide(Victoza)by pen. The starting dose is 0.6 mg once daily(day 0 to 7), followed by 1.2 mg once daily (day 8 to 35).<br>* Other names: Victoza;|
| Placebo Comparator: Placebo<br>See Intervention | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the immediate and delayed recall of a declarative memory task (word list recall) at time points indicated in time frame section. |  | Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 1 (Immediate Recall 2), Day 7 (Delayed Recall 2), Day 28 (Immediate Recall 3), Day 35 (Delayed Recall 3) | 
| Change from baseline in the immediate and delayed recall of an Episodic Memory Task (story recall) at the time points indicated in the Time Frame - section. |  | Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2) | 
| Change from baseline in performance on a two-dimensional object location task on day 1 and day 35. |  | Day -7, Day 1, Day 35 | 
| Change from baseline in performance on a working-memory task on day 1 and day 35. | Digit Span Test | Day -7, Day 1, Day 35 | 
| Change from baseline in immediate and delayed recall of a procedural memory task at the time points indicated in the Time Frame - section. | Finger tapping test | Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in resting metabolic rate on day 7, 28 and 35. | indirect calorimetry | Day 0 , Day 7 , Day 28 , Day 35 | 
| Change from baseline in serum/plasma concentrations of parameters involved in glucose metabolism on day 1,7,28, and 35. |  | Day -7, 1, 7, 28, 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Memory, GLP-1, Liraglutide, energy output, Memory facilitation, GLP-1 analogue