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NCT04404153 · ClinicalTrials.gov registry record · NA
Neurostimulation for Cognitive Enhancement in Alzheimer's Disease
A NA study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT04404153: Completed NA study, sponsored by Albert Einstein College of Medicine.
NCT04404153 is a NA study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04404153, a NA study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
The prevalence of Alzheimer's Disease (AD) is rising, but existing medications provide only modest control of cognitive decline and associated symptoms, and novel therapies are urgently needed. This randomized sham-controlled trial will determine if an innovative low-risk remotely-supervised transcranial Direct Current Stimulation (tDCS) applied over the area of the dorsolateral prefrontal cortex for 30 minutes at the intensity of 2 mA five times per week for 6 months at home can improve cognitive performance and symptoms and modulate neuroimaging markers of neuroplasticity in 100 patients with mild to moderate AD. If effective, this novel intervention can substantially enhance AD symptom management at home, improve quality of life of AD patients and their families, and reduce burden associated with this debilitating illness.
Primary Outcome
Change in The Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) was developed as an outcome measure for dementia interventions; its primary purpose was to be an index of global cognition in response to therapies. It assesses multiple cognitive domains across 11 items: Word Recall Task, Naming Objects and Fingers, Following Commands, Constructional Praxis, Ideational Praxis, Orientation, Word Recognition Task, Remembering Test Directions, Spoken Language, Comprehension and Word-F
Interventions
- DEVICE tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS.
- DEVICE tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver sham tDCS.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-03-25 |
| Est. Completion | 2026-02-19 |
| Phase | NA |
What the finished NCT04404153 record still lists
NCT04404153 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS. is the first listed.
NCT04404153 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04404153 about?
NCT04404153 is a clinical study titled "Neurostimulation for Cognitive Enhancement in Alzheimer's Disease". The prevalence of Alzheimer's Disease (AD) is rising, but existing medications provide only modest control of cognitive decline and associated symptoms, and novel therapies are urgently needed. This randomized sham-controlled trial will determine if an innovative low-risk remotely-supervised transcr...
What is the current status of trial NCT04404153?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2021-03-25. Estimated completion is 2026-02-19.
What interventions are being tested in trial NCT04404153?
The interventions under investigation include: tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS. (DEVICE), tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver sham tDCS. (DEVICE).
Who is sponsoring clinical trial NCT04404153?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04404153's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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