Identifying Potential Effects of Liraglutide on Degenerative Changes
Today Alzheimers disease can not be cured. Animal experiments have shown that the hormone GLP-1 can improve memory in Alzheimer-prone mice.
The investigators hypothesis is that a 6-month treatment with the GLP-1 receptor stimulating drug liraglutide will reduce the intracerebral amyloid deposition in the central nervous system (CNS) in patients with Alzheimer's disease (AD) and thereby reduce the clinical symptoms of the disease.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Neurodegenerative Changes in Alzheimer's Disease: Identifying Potential Effects of Liraglutide on Degenerative Changes|
- PIB PET scan [ Time Frame: PIB PET-scan at baseline and after 26 weeks ] [ Designated as safety issue: No ]Primarily to investigate whether 26 weeks of treatment with GLP-1 receptor liraglutide (Victoza ®) will change the intra-cerebral amyloid deposit in the CNS in patients with Alzheimer's disease assessed by PIB PET scan.
- Neuro-psychological tests [ Time Frame: At baseline, after 12 weeks and after 26 weeks ] [ Designated as safety issue: No ]To validate the cognitive functions using specific neuro-psychological test battery before and after treatment with liraglutide/placebo.
- FDG PET Scan [ Time Frame: FDG PET-scan at baseline and after 26 weeks ] [ Designated as safety issue: No ]To examine changes in glucose uptake in the CNS by FDG PET scan before and after 6 months of treatment with liraglutide/placebo
|Study Start Date:||January 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Drug
the GLP-1 receptor analog liraglutide is the active drug. The dose is 1.8mg daily
Liraglutide (Victoza ®), human GLP-1 analog produced using recombinant DNA technology in saccharomyces cerevisiae. Victoza ® is registered and approved for the treatment of type 2 diabetes.
Victoza ® stimulates glucose-dependent insulin secretion from β-cells and inhibits glucagon secretion, slows ventricle emptying and reduces body weight and body fat mass by affecting appetite regulation.
Form of administration: Liraglutide is a clear injection fluid, which comes in a prefilled disposable pen.
1 ml contains 6 mg of liraglutide in sterile water. There is added disodium phosphate and propylene glycol and the preservative phenol. A filled pen contains 18mg liraglutide in 3ml. NovoFine® needles are used.
Placebo Comparator: placebo
non active intervention
Drug: non-active study drug
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01469351
|Aarhus, Denmark, 8000|
|Principal Investigator:||Birgitte Brock, MD phD||University of Aarhus|