Identifying Potential Effects of Liraglutide on Degenerative Changes
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|ClinicalTrials.gov Identifier: NCT01469351|
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : April 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimers Disease||Drug: Liraglutide Drug: non-active study drug||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Neurodegenerative Changes in Alzheimer's Disease: Identifying Potential Effects of Liraglutide on Degenerative Changes|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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
- PIB PET scan [ Time Frame: PIB PET-scan at baseline and after 26 weeks ]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 ]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 ]To examine changes in glucose uptake in the CNS by FDG PET scan before and after 6 months of treatment with liraglutide/placebo
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469351
|Aarhus, Denmark, 8000|
|Principal Investigator:||Birgitte Brock, MD phD||University of Aarhus|