Liraglutide Effects on Memory in Healthy Subjects

University of Luebeck40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

liraglutideDRUG

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).

PlaceboDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Luebeck, Department of Neuroendocrinology

Lübeck, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2)

Secondary Outcomes

Change from baseline in resting metabolic rate on day 7, 28 and 35.

indirect calorimetry

Time frame: 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.

Time frame: Day -7, 1, 7, 28, 35

Data from ClinicalTrials.gov

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