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
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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|
|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
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|Ages Eligible for Study:||50 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Informed consent before study-related activity
- Adult competent persons
- Diagnosed with diagnosed Alzheimer's disease. With a MMSE score between 18-21 the diagnosis should be entirely based on the clinic, while diagnosis by MMSE with a score > 22 should be diagnosed by spinal puncture
- Age ≥ 50 years and ≤ 80 years
- Diabetes mellitus
- Clinically significant liver (s-ALT > 2 times upper reference or creatinine-clearance < 30 mL / min, assessed on Cockcroft-Gault normogram)
- Clinically significant anemia
- Other clinically relevant abnormal biochemical value
Current or former presence of one of the following diseases with clinical relevance:
- another CNS-illness other than diagnosed depression treated with SSRI or SSRI similar drugs.
- liver disease
- kidney disease
- endocrinological disease other than well controlled hypothyroidism
- Current or history of chronic or acute pancreatitis
- Any disease which the investigators believe may affect the study
- Patients treated with TCA or neuroleptics
- Known abuse of alcohol or drugs
- Known allergy to liraglutide or any of the other components (disodium phosphate dihydrate, propylene glycol and phenol)
- Participation in a clinical trial less than 3 months before inclusion in this study
- Persons who within a period of the last 2 years have participated in scientific experiments involving the use of isotopes, or who have had greater diagnostic tests performed using applied ionizing radiation
- If patients are treated with SSRI or SSRI similar drugs or antihypertensives this treatment should be stable
- Claustrophobia or other missing cooperation
- Severe overweight > 130kg
- Ferro-magnetic prosthesis, pacemaker or other metals incorporated in the body
- Significant abnormities in the brain detected by MR scanning
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|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||University of Aarhus|
|Other Study ID Numbers:||
|First Posted:||November 10, 2011 Key Record Dates|
|Last Update Posted:||April 19, 2013|
|Last Verified:||April 2013|
Central Nervous System Diseases
Nervous System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists