ELAD Study

• Conditions: Patients with mild Alzheimer’s dementia as defined by NINCDS-ADRDA Criteria for Probable Alzheimer’s dementia or meeting NIA-AA criteria for early AD, with MMSE =22 and a CDR Global score of 0.5 or 1 using the University of Washington on-line algorithm; MedDRA version: 14.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-000962-13-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-13
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 NIA-AA 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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 136

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified