Liraglutide Effects on Memory in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Dr. med. Volker Ott, University of Luebeck
ClinicalTrials.gov Identifier:
NCT01550653
First received: March 1, 2012
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: liraglutide
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Liraglutide Effects on Memory in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in performance on a working-memory task on day 1 and day 35. [ Time Frame: Day -7, Day 1, Day 35 ] [ Designated as safety issue: No ]
    Digit Span Test

  • 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) ] [ Designated as safety issue: No ]
    Finger tapping test


Secondary Outcome Measures:
  • Change from baseline in resting metabolic rate on day 7, 28 and 35. [ Time Frame: Day 0 , Day 7 , Day 28 , Day 35 ] [ Designated as safety issue: No ]
    indirect calorimetry

  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide
See "Intervention"
Drug: liraglutide
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 Name: Victoza
Placebo Comparator: Placebo
See "Intervention"
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550653

Locations
Germany
University of Luebeck, Department of Neuroendocrinology
Luebeck, Germany, 23538
Sponsors and Collaborators
University of Luebeck
Novo Nordisk A/S
Investigators
Principal Investigator: Volker Ott, MD University of Luebeck, Department of Neuroendocrinology
  More Information

No publications provided

Responsible Party: Dr. med. Volker Ott, Principal Investigator, University of Luebeck
ClinicalTrials.gov Identifier: NCT01550653     History of Changes
Other Study ID Numbers: Ott-NN-001
Study First Received: March 1, 2012
Last Updated: February 26, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Luebeck:
Memory
GLP-1
Liraglutide
energy output
Memory facilitation
GLP-1 analogue

Additional relevant MeSH terms:
Liraglutide
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 19, 2014