Status:
TERMINATED
TMS as a Treatment for Apathy in Alzheimer's Disease
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Alzheimer Disease
Apathy in Dementia
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
This proposal will demonstrate that non-invasive brain stimulation is able to modulate cortico-striatal circuits in neurodegenerative patients with apathy, and that doing so results in circuit-specifi...
Detailed Description
Apathy is among the most common neuropsychiatric symptoms in Alzheimer's Disease (AD), with prevalence estimates up to 72%. Apathy in AD is associated with significant morbidity, high caregiver burden...
Eligibility Criteria
Inclusion
- Age 50-80.
- A clinical diagnosis of Alzheimer's disease, including atypical variants of this (e.g., the behavioral/dysexecutive variant, the logopenic Primary Progressive Aphasia variant, Posterior Cortical Atrophy variant, etc.).
- Clinical Dementia Rating of 0.5 or mild 1.0 (MMSE equal to or greater than 22).
- Patients must be accompanied to visits by a study partner/informant (usually a spouse or adult child).
- Prominent symptoms of apathy reported by their primary caregiver/informant and verified with a score of greater than or equal to 45 on the informant version of the Apathy Evaluation Scale (AES-I).
Exclusion
- Any contraindication to MR-PET scanning (e.g., pacemakers, implanted metal, aneurysm clips, etc.)
- Any contraindication to receiving TMS (e.g., a history of seizures, cochlear implants)
- Involvement in any PET studies within 12 months.
- Clinical dependence on psychotropic medications believed to affect dopamine binding (e.g., certain antidepressants or especially neuroleptics). If the patient is clinically able to temporarily wean off of these, they will be included after the medication has been discontinued and fully eliminated (e.g., a duration of five half-lives). Subjects will also be excluded if they have a history of long-term use of these agents (particularly neuroleptics).
- Concurrent use of tobacco or illicit drugs, particularly those affecting dopamine transmission. Patients will be asked to refrain from using caffeine the morning of experimental procedures.
Key Trial Info
Start Date :
May 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05389644
Start Date
May 2 2024
End Date
October 28 2024
Last Update
May 15 2025
Active Locations (1)
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1
Martinos Center for Biomedical Imaging/Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129