Evaluating the effects of the novel GLP1 analogue, liraglutide, in patients with Alzheimer’s disease (ELAD study)

Study ID: 14887
Short Title: ELAD study
Organisation: Southern Health NHS Foundation Trust
Location: Moorgreen Hospital
Condition: Alzheimer's Disease
Main Specialty: Dementias
Expected End Date: 31/12/2018
Postcode: SO30 3JB
Contact Name: SHFT Research
Contact Email: research@southernhealth.nhs.uk
Active: Yes

Inclusion Criteria

1. Male/female aged 50-85.

2. Capable of giving and capacity to give informed consent.

3. A carer who can act as a reliable study partner.

4. Diagnosis of probable Alzheimer's disease according to NIAAA criteria.

5. Mini-Mental State Examination (MMSE) score of ?22.

6. Rosen Modified Hachinski Ischemic score ?4.

7. On stable medication for 3months? on or off Cholinesterase inhibitors.

8. Fluency in English and evidence of adequate premorbid intellectual functioning.

9.Likely to be able to participate in all scheduled evaluations and complete all required tests.

Exclusion Criteria

1.Any contraindications to the use of Liraglutide as per the Summary of Product Characteristics. (hepatic impairment, renal impairment with CKD stage 3 and above, inflammatory bowel disease).

2.Significant neurological disease other than AD that may affect cognition.

3.MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regards to their dementia.

4.Diabetes Mellitus.

5.Currently taking or having taken memantine on the 30 days prior to screening.

6.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).

7.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.

8. History of seizures, excluding febrile seizures in childhood.

9. 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.

10. Myocardial infarction within the last 1 year.

11. History of cancer within the last 5 years.

12. Other clinically significant abnormality on physical, neurological, laboratory, examination that could compromise the study or be detrimental to the patient.

13. History of alcohol or drug dependence or abuse within the last 2 years.

14. Current use of anticonvulsant, anti-Parkinson’s, anticoagulant (excluding the use of aspirin 325 mg/day or less) or narcotic medications.

15. 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.

16. Women of childbearing potential. Women who could become pregnant will be required to use adequate contraception throughout the trial.

17. Patients with a personal or family history of medullary thyroid carcinoma (MTC) and patients with multiple endocrine neoplasia type 2 (MEN2).

Study summary:

This is a 12-month, multicentre randomised double-blind Placebo-controlled Phase IIb study in patients with mild Alzheimer’s dementia (AD). We aim to recruit patients with mild Alzheimer’s dementia as defined by the National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) Criteria for Probable Alzheimer’s Dementia or meeting Dubois criteria for early AD, with Mini Mental State Evaluation score of at least 22 out of a maximum of 30 and a CDR Global score of 0.5 or 1 using the University of Washington on-line algorithm.

Patients will be randomised on a 1:1 ratio to receive liraglutide (1.8 mg daily by subcutaneous injection) or identical matching placebo. Liraglutide is marketed for use in patients with type 2 diabetes to reduce hyperglycaemia by increasing insulin secretion, but its specific mechanism of action does not cause hypoglycaemia in non-diabetic subjects. Since type 2 diabetes is a risk factor for AD, this study aims to investigate whether liraglutide has any effect on the glucose metabolism in the brains of patients with mild AD. This will be studied using [18F]FDG-PET imaging at baseline and after 12 months to determine whether there is any difference between liraglutidetreated subjects and those receiving placebo. Subjects will also have brain scans using MRI at baseline and after 12 months of treatment.

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