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NCT02190084 · ClinicalTrials.gov registry record · Phase 4

Repetitive Transcranial Magnetic Stimulation for Apathy in Alzheimer's Dementia

A Phase 4 study of Apathy and Alzheimer's Dementia, sponsored by Central Arkansas Veterans Healthcare System.

Completed
Registry status
Phase 4
Development phase
20
Enrollment target
1
Study location

NCT02190084: Completed Phase 4 study of Apathy and Alzheimer's Dementia, sponsored by Central Arkansas Veterans Healthcare System.

NCT02190084 is a Phase 4 study of Apathy and Alzheimer's Dementia that has completed, run by Central Arkansas Veterans Healthcare System. The registered enrollment target is 20 participants, below the 47-participant average among 6 other Apathy trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02190084, a Phase 4 study of Apathy and Alzheimer's Dementia, has completed, sponsored by Central Arkansas Veterans Healthcare System.

COMPLETED
Registry status
Phase 4
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

Alzheimer's Dementia (AD) is a major public health problem. Apathy, a profound loss of motivation, is seen in majority of patients with AD. Dysfunction of the front of the brain and loss of dopamine, a type of neurochemical, in this part of brain results in apathy. Presence of apathy is linked to deficits in planning sequential tasks such as keeping a routine. Patients with apathy have poor physical function and their caregivers experience extra burden. Unfortunately there are no good medications to treat apathy. FDA has approved the use of brain stimulation by a magnet known as repetitive transcranial magnetic stimulation (rTMS), for treatment of depression. rTMS increases dopamine when applied to frontal lobe of brain so we propose that rTMS would be a good treatment option for apathy in AD. Study hypotheses include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will improve apathy and executive function better than sham treatment in those with AD.

Primary Outcome

AES is an 18-item scale that assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks.

Interventions

  • DEVICE Neurostar repetitive transcranial magnetic stimulator

Study Locations (1)

Arkansas

  • Central Arkansas Veterans Healthcare System - Little Rock

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2014-05
Est. Completion 2019-07
Phase Phase 4

What the finished NCT02190084 record still lists

NCT02190084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 47-participant average among 6 other Apathy trials with a reported enrollment target (57% lower).

The record links to 2 conditions, with Apathy appearing as the primary indexed condition, and to 1 intervention - of which Neurostar repetitive transcranial magnetic stimulator is the first listed.

NCT02190084 reports a single indexed study location in Arkansas.

Frequently Asked Questions

What is clinical trial NCT02190084 about?

NCT02190084 is a clinical study titled "Repetitive Transcranial Magnetic Stimulation for Apathy in Alzheimer's Dementia". Alzheimer's Dementia (AD) is a major public health problem. Apathy, a profound loss of motivation, is seen in majority of patients with AD. Dysfunction of the front of the brain and loss of dopamine, a type of neurochemical, in this part of brain results in apathy. Presence of apathy is linked to de...

What is the current status of trial NCT02190084?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2014-05. Estimated completion is 2019-07.

What conditions does trial NCT02190084 study?

This clinical trial studies the following conditions: Apathy, Alzheimer's Dementia.

What interventions are being tested in trial NCT02190084?

The interventions under investigation include: Neurostar repetitive transcranial magnetic stimulator (DEVICE).

Who is sponsoring clinical trial NCT02190084?

This trial is sponsored by Central Arkansas Veterans Healthcare System, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02190084 being conducted?

This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT02190084, the US trial registry maintained by the National Library of Medicine. NCT02190084 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.