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Evaluating Liraglutide in Alzheimer's Disease | Clinical Trials | Clareo Health

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Evaluating Liraglutide in Alzheimer's Disease

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

NCT01843075•Imperial College London

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.

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. .

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (1)

Imperial College, Hammersmith Hospital

London, United Kingdom

Key Dates

Start Date

January 1, 2014

Primary Completion Date

December 1, 2019

Completion Date

December 1, 2019

Last Updated

June 10, 2019

Enrollment

204

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

Liraglutide

DRUG

Placebo

DRUG

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluating Liraglutide in Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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