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Alzheimer's DiseasePhase 2ELADNCT01843075

Evaluating Liraglutide in Alzheimer's Disease

A Phase 2 study testing Liraglutide in people with Alzheimer's Disease, run by Imperial College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a 12-month, multicentre randomised double-blind placebo-controlled Phase IIb study in patients with mild Alzheimer's dementia (AD). Patients will be randomised on a 1:1 ratio to receive liraglutide or matching placebo. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Liraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
204 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2014to Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving and capacity to give informed consent
  • An individual who can act as a reliable study partner with regular contact (combination of face to face visits / telephone contact acceptable) who has sufficient subject interaction to provide meaningful input into rating scales and, if necessary, supervise or perform the injections, as judged by the investigator
  • Diagnosis of Probable Alzheimer's disease according to Dubois criteria (Dubois, Feldman et al. 2007) or National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • Age from 50 years
  • Mini-Mental State Examination (MMSE) score of ≥20 and CDR-Global score of 0.5 or 1
  • Rosen Modified Hachinski Ischemic score ≤4
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  • On stable medication for 2 months before the screening visit; on or off cholinesterase inhibitors
  • Fluency in English and evidence of adequate premorbid intellectual functioning
  • Likely to be able to participate in all scheduled evaluations and complete all required tests

Who cannot join

  • Patients on treatment for diabetes mellitus
  • Any contraindications to the use of liraglutide as per the Summary of Product Characteristics (hepatic impairment, renal impairment with CKD stage 4 and above (eGFR <30 ml/min/1.73m2), inflammatory bowel disease). Patients with eGFR less than 45 ml/min/1.73m2 will have the renal function monitored very closely
  • Significant neurological disease other than AD that may affect cognition
  • MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regard to their dementia or vascular dementia fulfilling NINCDS-AIREN criteria
  • 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)
  • 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
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  • History of epilepsy, where seizures or treatment could have contributed to cognitive impairment
  • 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
  • Myocardial infarction within the last 1 year
  • History of cancer within the last 5 years, except localised skin cancer
  • Other clinically significant abnormality on physical, neurological or laboratory examination that could compromise the study or be detrimental to the patient
  • History of alcohol or drug dependence or abuse within the last 2 years
  • Current use of anticonvulsant, anti-Parkinson's, anticoagulant (excluding the use of aspirin 325 mg/day or less) or narcotic medications. Subjects on anticoagulants will be allowed, but will not have an arterial line inserted
  • 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
  • Women of childbearing potential. Women who could become pregnant will be required to use adequate contraception throughout the trial
  • Patients with a personal or family history of medullary thyroid carcinoma (MTC) and patients with multiple endocrine neoplasia type 2 (MEN2)
  • Any contraindications to MRI scanning

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Imperial College, Hammersmith Hospital

    London, W12 0NN

Other trials in United Kingdom

About this study

Official title: Evaluating the Effects of the Novel GLP-1 Analogue, Liraglutide, in Patients With Mild Alzheimer's Disease (ELAD Study)

This is a 12-month, multicentre randomised double-blind placebo-controlled Phase IIb study in patients with mild Alzheimer's dementia (AD). Patients will be randomised on a 1:1 ratio to receive liraglutide or matching placebo.

Read the detailed description

The investigators 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 20 out of a maximum of 30 and a CDR Global score of 0.5 or 1.

.

Being tested
Liraglutide, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

    Also called Victoza

    Daily subcutaneous injection

  • PlaceboDrug

    Daily subcutaneous injection

Study groups in NCT01843075
Study groupRoleWhat they receive
LiraglutideExperimentalDaily administration of 1.8 mg liraglutide by subcutaneous injection
Receives: Drug: Liraglutide
PlaceboPlacebo comparatorDaily administration of matched placebo by subcutaneous injection
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change in cerebral glucose metabolic rate

    The change in cerebral glucose metabolic rate from baseline to follow up (12 months) in the treatment group compared with the placebo group.

    Measured: 12 months

Secondary outcomes (5)

  1. The change in z-scores for the ADAS Exec, MRI changes, microglial activation, and CSF markers

    The change in z-scores for the ADAS Exec, MRI changes, microglial activation, and CSF markers

    Measured: 12 months

  2. The incidence and severity of treatment emergent adverse events

    The incidence and severity of treatment emergent adverse events or clinically important changes in safety assessments over 12 months.

    Measured: 12 months

  3. The change in microglial activation

    To establish whether there is a reduction in microglial activation in subjects with mild AD following daily subcutaneous injection of liraglutide for 1 year using TSPO PET scanning compared with subjects receiving placebo injections in a subgroup of patients

    Measured: 12 months

  4. The change in tau deposition

    The change in the hippocampal, entorhinal and other cortical changes in tau deposition in treatment group compared to the placebo group in a subgroup of subjects.

    Measured: 12 months

  5. The change in cortical amyloid

    Changes in levels of cortical amyloid load in treatment group compared to the placebo group in a subgroup of subjects.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01843075
Sponsor's protocol ID
U1111-1131-9252
Acronym
ELAD
Status last verified
Jun 2019
First submitted
24 Apr 2013
Last updated
10 Jun 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Edison P, Femminella GD, Ritchie C, Nowell J, Holmes C, Walker Z, Ridha B, Raza S, Livingston NR, Frangou E, Love S, Williams G, Lawrence R, Mcfarlane B, Archer H, Coulthard E, Underwood BR, Koranteng P, Karim S, Bannister C, Perneczky R, Prasanna A, Junaid K, McGuinness B, Nilforooshan R, Macharouthu A, Donaldson A, Thacker S, Russell G, Malik N, Mate V, Knight L, Kshemendran S, Holscher C, Mansouri A, Chester-Jones M, Holmes J, Tan T, Williams S, Ashraf A, Brooks DJ, Harrison J, Hinz R, Tadros G, Passmore AP, Ballard C. Liraglutide in mild to moderate Alzheimer's disease: a phase 2b clinical trial. Nat Med. 2026 Jan;32(1):353-361. doi: 10.1038/s41591-025-04106-7. Epub 2025 Dec 1.

    PubMed 41326666

  • Femminella GD, Frangou E, Love SB, Busza G, Holmes C, Ritchie C, Lawrence R, McFarlane B, Tadros G, Ridha BH, Bannister C, Walker Z, Archer H, Coulthard E, Underwood BR, Prasanna A, Koranteng P, Karim S, Junaid K, McGuinness B, Nilforooshan R, Macharouthu A, Donaldson A, Thacker S, Russell G, Malik N, Mate V, Knight L, Kshemendran S, Harrison J, Holscher C, Brooks DJ, Passmore AP, Ballard C, Edison P. Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer's disease: study protocol for a randomised controlled trial (ELAD study). Trials. 2019 Apr 3;20(1):191. doi: 10.1186/s13063-019-3259-x.

    PubMed 30944040

  • Muscogiuri G, DeFronzo RA, Gastaldelli A, Holst JJ. Glucagon-like Peptide-1 and the Central/Peripheral Nervous System: Crosstalk in Diabetes. Trends Endocrinol Metab. 2017 Feb;28(2):88-103. doi: 10.1016/j.tem.2016.10.001. Epub 2016 Oct 27.

    PubMed 27871675

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liraglutide in people with Alzheimer's Disease, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in cerebral glucose metabolic rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01843075, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.

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