Aβ Dynamics in LLMD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-04

Study Completion Date

2027-01-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Escitalopram for Agitation in Alzheimer's Disease

NCT03108846

Dementia

ACTIVE_NOT_RECRUITING PHASE3

Escitalopram Effects on CSF Amyloid Beta

NCT02161458

Amyloid Beta Protein

COMPLETED PHASE4

Progression Delaying Effect of Escitalopram in Alzheimer's Disease

NCT00702780

Alzheimer's Disease

COMPLETED NA

Aging Brain Changes, Executive Dysfunction and Depression

NCT00918684

Depression

COMPLETED PHASE4

Study of Escitalopram Versus Placebo in the Treatment of Depressive Syndrome in Alzheimer's Disease, Vascular Dementia, and Mixed Vascular and Alzheimer's Dementia

NCT00229333

Depressive Syndrome

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Both the study staff and the subjects will be blind to the study assignment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Escitalopram (ESC)

Group Type ACTIVE_COMPARATOR

Escitalopram Oxalate

Intervention Type DRUG

The daily dose of ESC/PBO will be 10 mg for the first 2 weeks, then increase to 20 mg as tolerated, with an option to reduce back to 10 mg if necessary.

Placebo (PBO)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daily dose of placebo will mimic that of ESC.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Escitalopram Oxalate

The daily dose of ESC/PBO will be 10 mg for the first 2 weeks, then increase to 20 mg as tolerated, with an option to reduce back to 10 mg if necessary.

Intervention Type DRUG

Placebo

Daily dose of placebo will mimic that of ESC.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lexapro ESC PBO

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No