Evaluating the effects of the novel GLP1 analogue, Liraglutide, in patients with Alzheimer's Disease (ELAD study)
| ISRCTN | ISRCTN89711766 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89711766 |
| EudraCT/CTIS number | 2013-000962-13 |
| ClinicalTrials.gov number | NCT01843075 |
| Secondary identifying numbers | 14887 |
- Submission date
- 18/11/2013
- Registration date
- 18/11/2013
- Last edited
- 13/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Alzheimer's disease (AD) is a devastating progressive neurodegenerative disease which affects 10% of people over 65 rising to 40% of those over 85 years, and is a major global healthcare burden. About 820,000 people in the UK and almost 35 million people worldwide live with dementia. Dementia costs the UK economy £23 billion per year, and US$604 billion worldwide. Liraglutide is already licensed for the treatment of diabetes and has shown promising results in studies carried out in animal models for AD. The aim of this study is to assess the safety and effectiveness of liraglutide in people with AD.
Who can participate?
Men and women aged between 50-85 years and diagnosed with Alzheimer's disease.
What does the study involve?
Participants will be randomly allocated to receive either liraglutide or an identical matching placebo (dummy). Brain scans of all patients will be performed at the Imperial College Clinical Imaging Facility (Hammersmith Campus) at the start of the study and after 12 months treatment with liraglutide or placebo.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
The study is led by Imperial College London and will be conducted at five major universities/sites in the UK.
When is the study starting and how long is it expected to run for?
The study opened to recruitment in December 2013 and will run for 3 years.
Who is funding the study?
Alzheimer's Society UK, Alzheimer's Drug Discovery Foundation, Van Geest Foundation and King's BRC, Novo Nordisk A/S.
Who is the main contact?
Dr Paul Edison
memory@imperial.ac.uk
Contact information
Scientific
Neurology Imaging Unit
Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom
| k.bouanane@imperial.ac.uk |
Study information
| Study design | Interventional 12-month multicentre randomised double-blind placebo-controlled Phase IIb treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluating the effects of the novel GLP1 analogue, Liraglutide, in patients with Alzheimer's Disease (ELAD study): a randomised, double-blind, placebo-controlled trial |
| Study acronym | ELAD |
| Study hypothesis | Liraglutide is effective in the treatment of Alzheimer's Disease (AD). More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14887 |
| Ethics approval(s) | London Riverside REC, 06/09/2013, ref: 13/LO/0699 |
| Condition | Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Disease: Alzheimer's Disease |
| Intervention | Patients will be randomised on a 1:1 ratio to receive liraglutide (1.8 mg daily by subcutaneous injection) or identical matching placebo. Liraglutide (Victoza) daily subcutaneous injection for 12 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Liraglutide |
| Primary outcome measure | Change in cerebral glucose metabolic rate; Timepoint(s): from baseline to follow up at 12-months |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/03/2013 |
| Overall study end date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Planned Sample Size: 206; UK Sample Size: 206; Description: 103 subjects per group (liraglutide and placebo) is the planned sample size |
| Participant 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. |
| Participant 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 patients condition or affect the patients 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-Parkinsons, 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). |
| Recruitment start date | 01/12/2013 |
| Recruitment end date | 01/03/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
W12 0NN
United Kingdom
Sponsor information
University/education
School of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- alzheimerssoc
- Location
- United Kingdom
No information available
No information available
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Novo Nordisk Global
- Location
- Denmark
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/04/2019 | 10/04/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/06/2024: The overall study end date was updated from 01/03/2016 to 30/06/2024.
10/04/2019: Publication reference added.
31/05/2018: No publications found, verifying study status with principal investigator.
