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Evaluating Liraglutide in Alzheimer's Disease (ELAD)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Imperial College London
Sponsor:
Collaborators:
King's College Hospital NHS Trust
University of Oxford
University of Southampton
Avon and Wiltshire Mental Health Partnership NHS Trust
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01843075
First received: April 24, 2013
Last updated: March 23, 2017
Last verified: September 2016
  Purpose

This is a 12-month, multicentre randomised double-blind placebo-controlled Phase IIb study in patients with mild Alzheimer's dementia (AD). 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.

Patients will be randomised on a 1:1 ratio to receive liraglutide or matching placebo.


Condition Intervention Phase
Alzheimer's Disease Drug: Liraglutide Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Effects of the Novel GLP-1 Analogue, Liraglutide, in Patients With Mild Alzheimer's Disease (ELAD Study)

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • The change in cerebral glucose metabolic rate [ Time Frame: 12 months ]
    The change in cerebral glucose metabolic rate from baseline to follow up (12 months) in the treatment group compared with the placebo group.


Secondary Outcome Measures:
  • The change in z-scores for the ADAS Exec, MRI changes, microglial activation, and CSF markers [ Time Frame: 12 months ]
  • The incidence and severity of treatment emergent adverse events [ Time Frame: 12 months ]
    The incidence and severity of treatment emergent adverse events or clinically important changes in safety assessments over 12 months.

  • The change in microglial activation [ Time Frame: 12 months ]
    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

  • The change in tau deposition [ Time Frame: 12 months ]
    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.

  • The change in cortical amyloid [ Time Frame: 12 months ]
    Changes in levels of cortical amyloid load in treatment group compared to the placebo group in a subgroup of subjects.


Estimated Enrollment: 206
Study Start Date: January 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide
Daily administration of 1.8 mg liraglutide by subcutaneous injection
Drug: Liraglutide
Daily subcutaneous injection
Other Name: Victoza
Placebo Comparator: Placebo
Daily administration of matched placebo by subcutaneous injection
Drug: Placebo
Daily subcutaneous injection

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01843075

Contacts
Contact: Paul Edison, PhD FRCPI +44 (0) 233133275 paul.edison@imperial.ac.uk
Contact: Victoria Scott, BSc +44 (0) 283833704 victoria.scott@imperial.ac.uk

Locations
United Kingdom
Imperial College, Hammersmith Hospital Recruiting
London, United Kingdom, W12 0NN
Contact: Victoria Scott, BSc    +44 (0) 283833704    victoria.scott@imperial.ac.uk   
Principal Investigator: Paul Edison, PhD FRCP(I)         
Sponsors and Collaborators
Imperial College London
King's College Hospital NHS Trust
University of Oxford
University of Southampton
Avon and Wiltshire Mental Health Partnership NHS Trust
Investigators
Principal Investigator: Paul Edison, PhD FRCPI Imperial College London
  More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01843075     History of Changes
Other Study ID Numbers: U1111-1131-9252
Study First Received: April 24, 2013
Last Updated: March 23, 2017

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 17, 2017