Evaluating the effects of the novel GLP1 analogue, Liraglutide, in patients with Alzheimer's Disease (ELAD study)

Phase 2

• Conditions: Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Disease: Alzheimer's Disease; Mental and Behavioural Disorders; Dementia in Alzheimer disease

• Registration Number: ISRCTN89711766
• Lead Sponsor: Imperial College of Science, Technology and Medicine (UK)

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30944040 protocol (added 10/04/2019)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-18
• Last Update Posted: 24 June 2024
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 206

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 3 months 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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in cerebral glucose metabolic rate; Timepoint(s): from baseline to follow up at 12-months

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures