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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Experimental | See "Intervention" |
|
| Placebo | Placebo Comparator | See "Intervention" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Volker Ott, MD | University of Luebeck, Department of Neuroendocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Luebeck, Department of Neuroendocrinology | Lübeck | 23538 | Germany |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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|
| Placebo | Drug |
|
| Day -7, 1, 7, 28, 35 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |