Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

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

Trial website

Contact information



Primary contact

Dr Kathy Bouanane


Contact details

Neurology Imaging Unit
Hammersmith Hospital
Du Cane Road
W12 0NN
United Kingdom

Additional identifiers

EudraCT number

2013-000962-13 number


Protocol/serial number


Study information

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 hypothesis

Liraglutide is effective in the treatment of Alzheimer's Disease (AD).

More details can be found at:

Ethics approval

London Riverside REC, 06/09/2013, ref: 13/LO/0699

Study design

Interventional 12-month multicentre randomised double-blind placebo-controlled Phase IIb treatment trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Disease: Alzheimer's Disease


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



Phase II

Drug names


Primary outcome measures

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

Secondary outcome measures

No secondary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned


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 type


Age group




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 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).

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Hammersmith Hospital
W12 0NN
United Kingdom

Sponsor information


Imperial College of Science, Technology and Medicine (UK)

Sponsor details

School of Medicine
Hammersmith Hospital
Du Cane Road
W12 0HS
United Kingdom

Sponsor type




Funder type


Funder name

Alzheimer's Society

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies


United Kingdom

Funder name

Alzheimer's Drug Discovery Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Van Geest Foundation and King's BRC (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Novo Nordisk

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype




Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes