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ELAD

UnknownPhase 2

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)

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

204

actual

Study population

Alzheimer's / cognition

Key I/E criterion

Primary endpoint

Cerebral glucose metabolic rate

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01843075
Org study IDU1111-1131-9252

Timeline

Milestones

Study first posted2013-04-30estimated
Last update posted2019-06-10actual
Study start2014-01actual (month precision)
Primary completion2019-12estimated (month precision)
Study completion2019-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Alzheimer's / cognition

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
4
Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

The incidence and severity of treatment emergent adverse events

Time frame:12 months

Treatment-emergent AEs (any)

descriptive, event

Other clinical outcomes

4 endpoints
Secondary/protocol endpoint/low confidence

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

Time frame:12 months

change from baseline, improvement

componentsADAS Exec z-score change, MRI changes, microglial activation, CSF markers

Secondary/protocol endpoint/low confidence

The change in microglial activation

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

The change in tau deposition

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

The change in cortical amyloid

Time frame:12 months

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

The change in cerebral glucose metabolic rate

Time frame:12 months

change from baseline, improvement

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.