Status:
COMPLETED
Repetitive Transcranial Magnetic Stimulation for Apathy in Alzheimer's Dementia
Lead Sponsor:
Central Arkansas Veterans Healthcare System
Conditions:
Apathy
Alzheimer's Dementia
Eligibility:
All Genders
55-91 years
Phase:
PHASE4
Brief 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, ...
Detailed Description
Objective: 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...
Eligibility Criteria
Inclusion
- Subjects age ≥ 55 years,
- Diagnosis of Alzheimer's dementia meeting the DSM-IV TR criteria,
- Apathy Evaluation Scale-Clinician (AES-C) score of ≥ 30,
- Mini Mental Status Examination (MMSE) ≥ 18,
- Subjects who clear the TMS adult safety scale (TASS)
- On stable dose of antidepressants or dementia medicines (if applicable) for at least two months
Exclusion
- Subjects taking medications known to increase the risk of seizures from the 2012 Beers criteria: Bupropion, chlorpromazine, clozapine, maprotiline, olanzapine, thioridazine, thiothixene, and tramadol.
- Subjects taking medications known to increase seizure threshold not listed in the Beers criteria but in the opinion of PI increase seizure threshold: tricyclic antidepressants, theophylline, methylphenidate, and high-dose thyroid supplementation.
- Subjects taking ototoxic medications: Aminoglycosides, Cisplatin.
- Subjects in current episode of major depression
- History of bipolar disorder
- Subjects with history of seizure or first degree relative with seizure disorder
- Subjects with implanted device: wearable or implantable cardioverter defibrillators, conductive, ferromagnetic, or other magnetic sensitive metals that are implanted or are non-removable within 30 cm of the treatment coil or those with cochlear implants
- Subjects with diagnosis of current alcohol related problems
- Subjects with history of stroke , aneurysm, or cranial neurosurgery
- Any condition that in the opinion of the study physician is likely to compromise their ability to safely participate in the study
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02190084
Start Date
May 1 2014
End Date
July 1 2019
Last Update
August 21 2019
Active Locations (1)
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1
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205