Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-22 @ 8:59 AM
Study NCT ID:
NCT01885806
Status:
UNKNOWN
Last Update Posted:
2013-06-25
First Post:
2013-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease
Sponsor:
Federal University of Minas Gerais
Organization:
Study Overview
Official Title:
Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease: a Randomised, Double-blind, Controlled Study
Status:
UNKNOWN
Status Verified Date:
2013-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.
Detailed Description:
This study aims to enroll 40 patients with mild and moderate Alzheimer's disease with apathy symptoms that will be randomized to receive rTMS or sham procedure. Subjects will be randomized in two arms (rTMS or sham procedure) in 1:1 proportion.
Eligibility criteria:
* Diagnosis of Alzheimer's disease, mild and moderate stage (MMSE range from 10 to 20);
* Diagnosis of apathy;
* age between 60 and 85 years-old;
* On stable doses of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for at least 6 months prior to enrollment;
The primary outcome measures is the Apathy Inventoire. Secondary outcome measures are the NPI score, ADAS-cog scores and the Zarit Burden Scale scores.
Eligibility criteria:
* Diagnosis of Alzheimer's disease, mild and moderate stage (MMSE range from 10 to 20);
* Diagnosis of apathy;
* age between 60 and 85 years-old;
* On stable doses of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for at least 6 months prior to enrollment;
The primary outcome measures is the Apathy Inventoire. Secondary outcome measures are the NPI score, ADAS-cog scores and the Zarit Burden Scale scores.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: