Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Capable of giving and capacity to give informed consent
An individual who can act as a reliable study partner with regular contact (combination of face to face visits / telephone contact acceptable) who has sufficient subject interaction to provide meaningful input into rating scales and, if necessary, supervise or perform the injections, as judged by the investigator
Diagnosis of Probable Alzheimer's disease according to Dubois criteria (Dubois, Feldman et al. 2007) or National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
Age from 50 years
Mini-Mental State Examination (MMSE) score of ≥20 and CDR-Global score of 0.5 or 1
Rosen Modified Hachinski Ischemic score ≤4
On stable medication for 2 months before the screening visit; on or off cholinesterase inhibitors
Fluency in English and evidence of adequate premorbid intellectual functioning
Likely to be able to participate in all scheduled evaluations and complete all required tests

Exclusion Criteria:

Patients on treatment for diabetes mellitus
Any contraindications to the use of liraglutide as per the Summary of Product Characteristics (hepatic impairment, renal impairment with CKD stage 4 and above (eGFR <30 ml/min/1.73m2), inflammatory bowel disease). Patients with eGFR less than 45 ml/min/1.73m2 will have the renal function monitored very closely
Significant neurological disease other than AD that may affect cognition
MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regard to their dementia or vascular dementia fulfilling NINCDS-AIREN criteria
Current presence of a clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
Current clinically significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study
History of epilepsy, where seizures or treatment could have contributed to cognitive impairment
Treatment with immunosuppressive medications (e.g. systemic corticosteroids) within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last 3 years
Myocardial infarction within the last 1 year
History of cancer within the last 5 years, except localised skin cancer
Other clinically significant abnormality on physical, neurological or laboratory examination that could compromise the study or be detrimental to the patient
History of alcohol or drug dependence or abuse within the last 2 years
Current use of anticonvulsant, anti-Parkinson's, anticoagulant (excluding the use of aspirin 325 mg/day or less) or narcotic medications. Subjects on anticoagulants will be allowed, but will not have an arterial line inserted
Use of experimental medications for AD or any other investigational medication or device within 60 days. Patients who have been involved in a monoclonal antibody study are excluded unless it is known that they were receiving placebo in that trial
Women of childbearing potential. Women who could become pregnant will be required to use adequate contraception throughout the trial
Patients with a personal or family history of medullary thyroid carcinoma (MTC) and patients with multiple endocrine neoplasia type 2 (MEN2)
Any contraindications to MRI scanning