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COGDYS-GLP1
CompletedPhase 3Cognitive Dysfunction and Glucagon-like Peptide-1 Agonists
Exploring the Neural Substrates of Cognitive Dysfunction With Glucagon-like Peptide-1 Agonists
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
21
actual
Study population
Alzheimer's / cognition, Psychiatric (schizophrenia / bipolar / depression)
Key I/E criterion
—
Primary endpoint
•Executive function
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Informed consent before study-related activity
2. Individuals between the ages of 18 and 45 who meet DSM-5 criteria for bipolar disorders or depressive disorders
3. Below-average (i.e. 1 standard deviation below norm) performance in the TMTB.
4. Individuals must be receiving guideline concordant pharmacotherapy, in stable doses, without withdrawal or addition of medication in the last month.
Exclusion criteria
1. Diagnosis of possible or probable AD, MCI, or any other dementia
2. History of neurological disorder (ischemic attacks, carotid bruits, or lacunes upon MRI scan), or evidence of neurologic or other physical illness that could produce cognitive deterioration
3. Individuals in a severe mood episode, defined as a Hamilton Depression Rating scale 17- item (HAMD-17) total score of >23 or a Young Mania Rating Scale (YMRS) total score of >20.
4. Actively suicidal or evaluated as being a suicide risk (operationalized as a score of ≥3 on HAMD-17 suicide item and/or by clinical assessment).
5. Substance use disorder within 3 months before screening or a positive baseline toxicology screen.
6. Currently being treated for diabetes, with oral hypoglycemic agents and/or insulin, as these medications affect glucose and insulin levels, as well as the HOMA-IR calculation.
7. Presence of absolute or relative contraindication to liraglutide (e.g. hepatic impairment, renal impairment with CKD stage 3 and above, personal or familial history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2)
8. History of alcoholism; history of pancreatitis or pancreatic cancer
9. Presence of clinically unstable general medical illness.
10. Pregnancy or breastfeeding women.
Endpoints (2)
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
1 endpointExecutive function
Time frame:4 weeks
change from baseline, improvement
Other (unclassified)
1 endpointResting-state functional network connectivity
Time frame:4 weeks
change from baseline, descriptive
Provenance
Sources
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.