Repetitive Transcranial Magnetic Stimulation for Apathy in Alzheimer's Dementia

Completed · Phase 4 · Has a placebo group

Conditions studied: Apathy, Alzheimer's Dementia

In brief

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.

Key facts

Study ID

NCT02190084

Run by

Central Arkansas Veterans Healthcare System

People needed

20

Starts

2014-05-01

Expected to finish

2019-07-01

Last updated by the study team

2019-08-21

Who can join

Age: 55 and older, up to 91. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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