Repetitive Transcranial Magnetic Stimulation for Apathy in Alzheimer's Dementia
Condition: Apathy; Alzheimer's Dementia
MeSH terms: Dementia; Alzheimer Disease
Study type: Interventional
Phase: Phase 4

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.
    

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 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.

      Specific Aims: To determine the efficacy of rTMS to the dorsolateral prefrontal cortex
      (DLPFC) in treating apathy in mild AD in comparison to sham treatment.

      • To compare the efficacy of rTMS to the DLPFC on executive function in mild AD in comparison
      to sham treatment.

      Research Plan: Current study is a prospective randomized sham controlled study of daily rTMS.

      Methods: Up to 500 subjects will be pre-screened to enroll 100 subjects for screening and
      randomizing up to 50 subjects to analyze 20 completers. Subjects with mild AD and apathy will
      be randomly assigned to rTMS or sham treatment after consent. All subjects will be tested for
      memory, behavioral problems, functioning and caregiver burden. Apathy will be assessed using
      the Apathy Evaluation Scale. Memory, executive function, functional status and caregiver
      burden will be assessed. Subjects will receive daily treatments for 4 weeks with either rTMS
      or sham coil for a total of 20 treatments. Neither the subject nor the investigators will
      know which treatment the subject is receiving. Testing will be repeated at the end of 4 weeks
      and at 8 and 12 weeks after treatment.
    

Intervention name(s): Neurostar repetitive transcranial magnetic stimulator
Intervention type(s): Device
Intervention description(s): The active procedure will stimulate at 120% motor threshold for 4 seconds at a frequency of 10 Hz, with an inter-train interval of 26 seconds for a total of 3,000 pulses. 20 treatment sessions are given over a four week period.
Other intervention name(s): •rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: apathy; Alzheimer's; executive function