Depression treatment may alter Alzheimer's biomarkers, study suggests
NCT ID NCT05004987
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether treating depression with a common antidepressant (escitalopram) can change brain and blood markers linked to Alzheimer's disease. Researchers will compare the drug to a placebo in 60 adults aged 60 and older who have major depression but no memory problems. The goal is to understand how depression treatment might affect Alzheimer's risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2022
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
60 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Alzheimer disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
-
Nathan S. Kline Institute for Psychiatric Research
RECRUITINGOrangeburg, New York, 10962, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a massive data registry crack the code of Parkinson's and related brain diseases?
- Can a gentle electric current calm the mind in Alzheimer's?
- Alzheimer's vaccine aims to clear amyloid before memory fades
- Blood, eye, and brain scans team up to spot Alzheimer's earlier
- Can an antipsychotic restore feelings in people with depression?
- Can a home device slow Alzheimer's? pilot study tests pulsed electromagnetic therapy