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Trial · Interventional

Status unknownPhase 2Registry data

Evaluating Liraglutide in Alzheimer's Disease

Short name ELAD

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
204 participants (actual)
Sponsor
Imperial College London · Other
Design
Randomized · Quadruple masking
Countries
1 country

United Kingdom

Start
Jan 2014
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
First posted
30 Apr 2013 (estimated)
Last update posted
10 Jun 2019
Conditions
Alzheimer's Disease

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017201820192020
  1. Ph 2

    ELAD

    NCT01843075

    Jan 2014 to est. Dec 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Liraglutide

    Daily administration of 1.8 mg liraglutide by subcutaneous injection

  • Placebo comparator

    Placebo

    Daily administration of matched placebo by subcutaneous injection

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The change in cerebral glucose metabolic rate

    Time frame · 12 months

    Registry description

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

Secondary outcomes(5)
  1. The change in z-scores for the ADAS Exec, MRI changes, microglial activation, and CSF markers

    Time frame · 12 months

    Registry description

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

  2. The incidence and severity of treatment emergent adverse events

    Time frame · 12 months

    Registry description

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

  3. The change in microglial activation

    Time frame · 12 months

    Registry description

    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

  4. The change in tau deposition

    Time frame · 12 months

    Registry description

    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.

  5. The change in cortical amyloid

    Time frame · 12 months

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

5 results

Liraglutide in mild to moderate Alzheimer's disease: a phase 2b clinical trial.

Edison et al. 2026Nature medicinecited by 55

PMID 41326666PMC12823385DOI 10.1038/s41591-025-04106-7PUB-41326666

CC BY5 results

More studies

1 study on this page

Indexing hint: Clinical trial · 2019

Corrected

Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer's disease: study protocol for a randomised controlled trial (ELAD study).

Femminella et al. 2019Trialscited by 189

PMID 30944040PMC6448216DOI 10.1186/s13063-019-3259-xPUB-30944040

CC BY

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedMuscogiuri 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. PMID 27871675

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Capable of giving and capacity to give informed consent 2. 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 3. 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 4. Age from 50 years 5. Mini-Mental State Examination (MMSE) score of ≥20 and CDR-Global score of 0.5 or 1 6. Rosen Modified Hachinski Ischemic score ≤4 7. On stable medication for 2 months before the screening visit; 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. Patients on treatment for diabetes mellitus 2. 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 3. Significant neurological disease other than AD that may affect cognition 4. MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regard to their dementia or vascular dementia fulfilling NINCDS-AIREN criteria 5. 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) 6. 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 7. History of epilepsy, where seizures or treatment could have contributed to cognitive impairment 8. 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 9. Myocardial infarction within the last 1 year 10. History of cancer within the last 5 years, except localised skin cancer 11. Other clinically significant abnormality on physical, neurological or laboratory examination that could compromise the study or be detrimental to the patient 12. History of alcohol or drug dependence or abuse within the last 2 years 13. 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 14. 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 15. Women of childbearing potential. Women who could become pregnant will be required to use adequate contraception throughout the trial 16. Patients with a personal or family history of medullary thyroid carcinoma (MTC) and patients with multiple endocrine neoplasia type 2 (MEN2) 17. Any contraindications to MRI scanning

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