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Completed

NCT Number: NCT01550653

Liraglutide Effects on Memory in Healthy Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of Luebeck, Department of Neuroendocrinology

Lübeck, 23538, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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).

Other names: Victoza

Placebo

Drug

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  4. Change from baseline in performance on a working-memory task on day 1 and day 35.

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

    Digit Span Test

  5. Change from baseline in immediate and delayed recall of a procedural memory task 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)

    Finger tapping test

Secondary outcomes

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

    Time frame: Day 0 , Day 7 , Day 28 , Day 35

    indirect calorimetry

  2. 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

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2012
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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