Alzheimer's disease MedDRA version: 14.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Victoza
Product Name: Victoza
Pharmaceutical Form: Solution for injection
Sponsors
Dept. of Pharmacology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with AD by MMSE score and/or spinal puncture (If MMSE score is between 18-21 the patient is diagnosed by clinical symptoms only. If the MMSE score is > 22 a spinal puncture will be performed to diagnose the patient) Age = 50 years and = 80 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Diabetes mellitus Liver or kidney insufficiency (alanine transferase levels more tha twice upper normal, plasma creatinine > 130µmol/l), clinical relevant anaemia Current or earlier presence of another CNS disease (except for well-treated depression) or clinical relevant liver disease, kidney disease or endocrinological disease (except hypothyreoism). Current or history of chronic or acute pancreatitis If patients are treated with SSRI or SSRI similar drugs or antihypertensives this treatment should be stable Claustrophobia or other missing co-orporation Severe overweight > 130kg Ferro-magnetic prosthesis, pacemaker or other metals incorporated in the body Significant abnormities in the brain detected by MR scanning Known abuse of alcohol or drugs Every disease or treatment that the head investigator considers to have a possible effect on results of the study Allergy to the drugs or diagnosing procedure used in the study Participation in a clinical study 3 months prior to inclusion in this study Patients who have previously participated in investigations with isotopes or ionizing radiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the effect of a 6 month treatment course with Victoza, a GLP-1 receptor agonist, on intracerebral amyloid aggregations determined by Pittsburgh Compound B PET-scans.;Secondary Objective: To examine the effect of a 6 month treatment course with Victoza, a GLP-1 receptor agonist, on the clinical course of AD as determined by validated neuropsychological tests (MMSE and Addenbrookes cognitive evaluation test). Secondary 2: To examine the effect of a 6 month treatment course with Victoza, a GLP-1 receptor agonist, on FDG metabolism in the brain as determined by PET-scans To examine the effect of a 6 month treatment course with Victoza, a GLP-1 receptor agonist, by MR scans. ;Primary end point(s): Pittsburgh Compound B PET scanning will be used to examine the primary objective of the study. Positron emission tomography (PET) scanning is an establisehed method for the demonstration of CNS changes caused by AD, including changes in deposits of amyloid. In AD patients, PET can be used to investigate changes in glucose metabolism, different neurotransmitter systems, neuroinflammation and protein deposits, amyloid deposits in particular. Amyloid beta accumulations are crucial patological findings in AD. Recently, amyloid tracers have been developed for PET which makes in vivo amyloid visualisation possible. It has been shown that the carbon-11 labelled Pittsburgh Compound B (PiB) PET tracer can be used to study amyloid deposits in living humans. PiB was among the first PET tracers to visualise amyloid and its effect is among the most well documented. Patients are not expected to experience any short- or long-term discomfort from the PET scans, apart from that assosiated to the insertion of cannulas. ;Timepoint(s) of evaluation of this end point: January 2013 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary1: To study the effect of a 6 month treatment course with liraglutide we will use validated neuropsychological tests (MMSE and Addenbrookes cognitive evaluation test) developed to characterization of disease progression in patients with AD. Secondary2: Moreover, we want to examine the effect of a 6 month treatment course with liraglutide, on FDG metabolism in the brain as determined 18F-flouro-2-deoxy-glucose PET-scans (FDG PET). A recent study have demonstrated that the glucose-analog 18F-flouro-2-deoxy-glucose PET tracer can be used to monitor the progressive reduction in cerebral glucose metabolism in patients with AD before clinical symptoms appear. Secondary3: At the 1st and last visit a perfusion-weighted MR scan of the brain will be performed. The perfusion-weighted MR-scan is a supplying marker for the severity of Alzheimer’s disease and can improve the sensitivity of the study drug’s effect in the brain. ;Timepoint(s) of evaluation of this end point: January 2013 | — |
Countries
Denmark
Outcome results
None listed