RECRUITING

Aβ Dynamics in LLMD

Conditions

Alzheimer Disease Major Depressive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Depression Treatment and Aβ Dynamics: A Study of Alzheimer's Disease Risk (ABD Study)

Quick Facts

Study Start:2022-02-04

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05004987

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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)

Inclusion Criteria

Exclusion 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.

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)

Contacts and Locations

Study Contact

Antero Sarreal, MD

CONTACT

845-398-6532

Antero.sarreal@nki.rfmh.org

Chelsea Reichert Plaska, PhD

CONTACT

845-398-5583

Chelsea.reichert@nki.rfmh.org

Principal Investigator

Nunzio Pomara, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Nathan S. Kline Institute for Psychiatric Research

Orangeburg, New York, 10962

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Nunzio Pomara, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-04

Study Completion Date2026-06

Study Record Updates

Study Start Date2022-02-04

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Alzheimer Disease
Major Depressive Disorder