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Aβ Dynamics in LLMD

StatusRecruiting
PhasePhase 4
Started2022-02-04
View on ClinicalTrials.gov ↗

Amendment history

2026-05-04
Study Status v7
Primary completion date2026-09-30→2026-12-31
Completion date2027-01-29→2027-06-30
2025-06-06
Study Status, Study Design v6
Primary completion date2026-04→2026-09-30
Completion date2026-06→2027-01-29
Enrollment target90→60
2024-08-28
Study Status, Eligibility v5
Eligibility criteria+69 characters
[...] (MMSE) >27. Clinical Dementia Rating Scale (CDR) Global of 0*. A score of 85 or greater on the RBANS delayed memory index [...] typing and plasma drug levels. Only individuals with normal hepaticor andnon-clinically renalsignificant functionabnormalities includingon normalroutine creatininelaboratory clearancetests, will be included. If study partner is not available, the CDR will be skipped. Exclusion Criteria: History of brain tumor, MRI evidence of [...]
2023-10-31
Study Status, Eligibility v4
Eligibility criteria+278 characters
[...] y. Adequate auditory acuity and normal-to-corrected vision. Have a reliable and competent study partner who can accompany the subject to the Screening Visit to verify absence of impairment in cognitive functions or activities of daily living. Willing to undergo brain MRI, urine drug screen and blood sa [...] a for current or past diagnosis of any psychiatric disorder other than recurrent MDD including(e.g., schizophrenia, bipolar disorder, dysthymic disorder, panic disorder, agoraphobia, specific phobia, social phobia, obsessive compulsive disorder, post-traumatic disorder, or any psychotic disorder) [...] [...]
2022-12-29
Study Status v3
Re-verified, no change to tracked fields
Show 2 earlier versions
2022-02-08
Study Status v2
Start dateestimated 2021-11-02→confirmed 2022-02-04
2021-11-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2021-10-01→2021-11-02
Study sitesdetails revised at 2 of 2 sites
2021-08-12
Original filing
NYU Langone Health
394 trials monitored
See 18 trials at risk
Depression
2,976 trials monitored
See 162 trials at risk
Alzheimer's Disease
1,140 trials monitored
See 62 trials at risk
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).
Trial Details
NCT Number NCT05004987
Lead Sponsor NYU Langone Health
Collaborators: National Institute on Aging (NIA)
Conditions Alzheimer Disease, Major Depressive Disorder
Enrollment 60 participants
Start Date 2022-02-04
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-06