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New treatment option for Alzheimer Disease
Official title Aβ Dynamics in LLMD
ClinicalTrials.gov ID: NCT05004987
What this study is testing
What is Escitalopram Oxalate?
Escitalopram Oxalate is an investigational medicine, given as an once-daily, being studied as a potential treatment for alzheimer disease.
Also referred to as Lexapro, ESC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Male and female people, age 60+ years inclusive, at the time of signing the informed consent.
- Meeting Structured Clinical Interview (SCID-5-RV) for DSM-5 criteria for Major depressive disorder.
- Montgomery-Åsberg Depression Rating Scale (MADRS) ≥18.
- Have results of a physical examination, neurological examination, vitals, and EKG within normal limits at screening.
- Cognitively unimpaired at screening visit as defined by Mini-Mental State Examination (MMSE) \>27.
You likely can't join if
- History of brain tumor, MRI evidence of brain damage or brain disease including significant trauma, hydrocephalus, seizures, or confluent (or more...
- Mental retardation, or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders).
- people with a Fazekas scale \>2.
- 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...
- A current significant risk for suicidality based on the Columbia-Suicide-Severity Rating Scale (C-SSRS).
- Insulin dependent diabetes.
See the full eligibility criteria
- Male and female people, age 60+ years inclusive, at the time of signing the informed consent.
- Meeting Structured Clinical Interview (SCID-5-RV) for DSM-5 criteria for Major depressive disorder.
- Montgomery-Åsberg Depression Rating Scale (MADRS) ≥18.
- Have results of a physical examination, neurological examination, vitals, and EKG within normal limits at screening.
- Cognitively unimpaired at screening visit as defined by Mini-Mental State Examination (MMSE) \>27.
- Clinical Dementia Rating Scale (CDR) Global of 0\ .
- A score of 85 or greater on the RBANS delayed memory index score.
- 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.
- Medically stable with no significant cerebrovascular, neurological, or systemic disease expected to interfere with the study.
- Adequate auditory acuity and normal-to-corrected vision.
- Willing to undergo brain MRI, urine drug screen and blood sampling for routine laboratory testing, lumbar puncture, APOE genotyping and plasma drug levels.
- 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.
- 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.
- Mental retardation, or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders).
- people with a Fazekas scale \>2.
- 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...
- A current significant risk for suicidality based on the Columbia-Suicide-Severity Rating Scale (C-SSRS).
- Insulin dependent diabetes.
- Evidence of clinically relevant or unstable cardiac, pulmonary, endocrine or hematological conditions.
- Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
- Positive urine drug screen for illicit drugs.
- History of poor tolerance to, poor response to, or ongoing treatment with escitalopram.
- If taking antidepressants, currently taking fluoxetine, due to the length of time required to washout.
- 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...
- For people 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Orangeburg, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Orangeburg, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.