TMS as a Treatment for Apathy in Alzheimer's Disease (NCT05389644) | Clinical Trial Compass
TerminatedNot Applicable
TMS as a Treatment for Apathy in Alzheimer's Disease
Stopped: Unable to fulfill recruitment goals
United States3 participantsStarted 2024-05-02
Plain-language 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-specific increases in FC and DA availability. These circuit changes will be accompanied by changes in specific behavioral dimensions of apathy. This work will lead to larger studies which develop personalized, circuit-specific neuromodulation strategies for AD patients suffering from this intractable neuropsychiatric symptom.
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Changes in resting-state connectivity (FC).
Timeframe: 1 hour
2
Changes in dopamine (DA) availability.
Timeframe: 1 hour
3
Changes in fMRI activation on an apathy related task
. 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.