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NCT01876823 · ClinicalTrials.gov registry record · Phase 2
Memantine Plus Es-citalopram in Elderly Depressed Patients With Cognitive Impairment
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT01876823 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 60 participants.
The verdict
NCT01876823, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
Alzheimer's disease (AD), the most common dementing disorder of later life, is a major cause of disability and death in the elderly. Although a number of theoretical causes exist, the etiology of AD is still unknown. Consequently, the focus of treatments has been palliative, designed to ameliorate AD symptoms. Recent efforts, however, have revealed some surprising data suggesting that cholinesterase inhibitors (AchEIs), used over the last decade, and recently released memantine (an N-methyl-D-aspartate (NMDA) receptor antagonist), may confer protection to neurons. Thus, they may offer a slowing of cognitive decline and/or improvement in behavioral symptoms associated with memory impairment. Over the last decade, it has been well documented that mild cognitive impairment (MCI) increases the risk of conversion to AD and that coincident depression and MCI (Dep-MCI) further increases the risk 2 to 3 fold. The primary focus of this line of investigation is to treat the very high risk to dement patient population with Dep-MCI, before they develop AD, in the hopes of delaying AD onset. Memantine had not been studied in DEP-MCI patients. Since treatment of these patients with combined antidepressant and AChEIs has been associated with cognitive improvement in pilot studies, we explore whether treatment of DEP-MCI with memantine in addition to antidepressant treatment would benefit cognitive performance and lead to a low rate of conversion to dementia. We evaluate the cognitive and antidepressant benefit of combined open-label es-citalopram and memantine treatment over 48 weeks in a DEP-CI sample.
Interventions
- DRUG Memantine
- DRUG es-citalopram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2006-04 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01876823
The ClinicalTrials.gov registry entry for NCT01876823 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Memantine is the first listed.
NCT01876823 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01876823 about?
NCT01876823 is a clinical study titled "Memantine Plus Es-citalopram in Elderly Depressed Patients With Cognitive Impairment". Alzheimer's disease (AD), the most common dementing disorder of later life, is a major cause of disability and death in the elderly. Although a number of theoretical causes exist, the etiology of AD is still unknown. Consequently, the focus of treatments has been palliative, designed to ameliorate A...
What is the current status of trial NCT01876823?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2006-04. Estimated completion is 2010-03.
What interventions are being tested in trial NCT01876823?
The interventions under investigation include: Memantine (DRUG), es-citalopram (DRUG).
Who is sponsoring clinical trial NCT01876823?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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