| NCT ID | NCT05004987 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | NYU Langone Health |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-02-04 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2022-02-04 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will examine the biological factors that may modulate the relationship between depression and the development of Alzheimer's disease (AD). Since the direction of causation between depression and the biological factors associated with AD is unknown, the only way to understand cause and associated risk is to treat the depressive symptoms and examine the effects on AD biomarkers. The study involves an FDA-approved treatment for major depressive disorder. It will compare the SSRI antidepressant escitalopram with placebo. The hypothesis is that a reduction in depressive symptoms will be associated with a normalization of CSF AD biomarkers as well as peripheral inflammatory markers. This research would contribute to fundamental knowledge about potentially modifiable risks of Alzheimer's disease (AD).
Eligibility Criteria
Inclusion Criteria: 1. Male and female subjects, age 60+ years inclusive, at the time of signing the informed consent. 2. Meeting Structured Clinical Interview (SCID-5-RV) for DSM-5 criteria for Major depressive disorder. 3. Montgomery-Åsberg Depression Rating Scale (MADRS) ≥18. 4. Have results of a physical examination, neurological examination, vitals, and EKG within normal limits at screening. 5. Cognitively unimpaired at screening visit as defined by Mini-Mental State Examination (MMSE) \>27. 6. Clinical Dementia Rating Scale (CDR) Global of 0\*. 7. A score of 85 or greater on the RBANS delayed memory index score. 8. Fluent in English, because some of the instruments used in this study have not been translated and validated in other languages, and are able to read at a 6th grade level or equivalent, as determined by the PI. 9. Medically stable with no significant cerebrovascular, neurological, or systemic disease expected to interfere with the study. 10. Adequate auditory acuity and normal-to-corrected vision. 11. Willing to undergo brain MRI, urine drug screen and blood sampling for routine laboratory testing, lumbar puncture, APOE genotyping and plasma drug levels. 12. Only individuals with normal or non-clinically significant abnormalities on routine laboratory tests, will be included. * If study partner is not available, the CDR will be skipped. Exclusion Criteria: 1. History of brain tumor, MRI evidence of brain damage or brain disease including significant trauma, hydrocephalus, seizures, or confluent (or more extensive) white matter hyperintensities. 2. Mental retardation, or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders). 3. Subjects with a Fazekas scale \>2. 4. Significant history of alcoholism or drug abuse in the past 2 years. Fulfilling SCID-5-RV/DSM-5 criteria for current or past diagnosis of any psychiatric disorder (e.g., schizophrenia, bipolar disorder, or any psychotic disorder) other than recurrent MDD or anxiety disorders (e.g., panic disorder, agoraphobia, etc.). 5. A current significant risk for suicidality based on the Columbia-Suicide-Severity Rating Scale (C-SSRS). 6. Insulin dependent diabetes. 7. Evidence of clinically relevant or unstable cardiac, pulmonary, endocrine or hematological conditions. 8. Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging. 9. Positive urine drug screen for illicit drugs. 10. History of poor tolerance to, poor response to, or ongoing treatment with escitalopram. 11. If taking antidepressants, currently taking fluoxetine, due to the length of time required to washout. 12. Treatment with following medications will not be permitted. In some cases, medications will be allowed if medically prescribed and dose regimen stable. Note: Some medications (e.g., amphetamines, opiates) may appear on the routine urine drug test in the screening period but can be allowed as per protocol. * For subjects taking prescribed psychoactive medications and supplements (i.e., opioids, amphetamines, amphetamine-like substances, and cannabinoids), must be on a stable dose for 1 month prior to randomization. * Anti-Parkinsonian medications (carbidopa/levodopa, amantadine, bromocriptine, pergolide, selegiline). * Cholinesterase inhibitors and memantine * Continuous aspirin (any dosage) use which can affect platelet function is prohibited. Exception: If participant is on low dose aspirin for prophylaxis and is willing to temporarily discontinue prior to research blood draw (i.e., 2 days before). * Continuous use of other medications which are also known to affect platelet function, including nonsteroidal anti-inflammatory drugs (NSAIDs), anti-histamines. Exception: If participant is taking medication continuously and is willing to temporarily discontinue prior to research blood draw (i.e., 2 days before)
Contact & Investigator
Nunzio Pomara, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05004987 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05004987 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05004987 currently recruiting?
Yes, NCT05004987 is actively recruiting participants. Contact the research team at Antero.sarreal@nki.rfmh.org for enrollment information.
Where is the NCT05004987 trial being conducted?
This trial is being conducted at New York, United States, Orangeburg, United States.
Who is sponsoring the NCT05004987 clinical trial?
NCT05004987 is sponsored by NYU Langone Health. The principal investigator is Nunzio Pomara, MD at NYU Langone Health. The trial plans to enroll 60 participants.
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