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Deep Repetitive Transcranial Magnetic Stimulation (rTMS) of the Precuneus for Alzheimer Disease (AD)

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Conditions

Alzheimer's DiseaseAlzheimer DiseaseDementia Alzheimer TypeMild Alzheimer's DiseaseModerate Alzheimer's DiseaseAlzheimer's Disease (AD)Alzheimer's DementiaClinical Trialdeep repetitive transcranial magnetic stimulation (deep rTMS)precuneusMild-to-Moderate Probable Alzheimer's Dementia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if using deep repetitive transcranial magnetic stimulation (rTMS) targeting the precuneus is feasible, tolerable, and potentially efficacious for memory in Probable Alzheimer's Dementia. Previous work studying rTMS in Alzheimer's is mixed, but recent work studying rTMS of the precuneus is encouraging for both its short-term and long-term effects. The main questions this study aims to answer are: * Is deep rTMS of the precuneus feasible and tolerable in Alzheimer's? * Are there signs of positive brain changes in response to deep rTMS? * Is deep rTMS potentially efficacious for memory in Alzheimer's? Researchers will compare active stimulation to placebo stimulation while obtaining memory testing and measurements of the brain (imaging, scalp electrode measurements, bloodwork) to see if active treatment works to treat mild-to-moderate probable Alzheimer's Dementia. Participants will: * Engage with memory testing, brain scans, and bloodwork during a comprehensive assessment * Visit the clinic 3 times for 12 consolidated rTMS sessions, followed by 4 once weekly maintenance sessions * Be offered a full open-label active treatment course after completing their treatment course if they are initially in the placebo group

Official Title

Protocol for Maintaining and Improving Mental Status in Alzheimer's Disease (PROMIS-AD): a Pilot Study of Repetitive Transcranial Magnetic Stimulation of the Precuneus for Alzheimer's Disease

Quick Facts

Study Start:2024-10-17
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06597942

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 60-100 at the start of the study
  2. * Established diagnosis of Alzheimer's Clinical Syndrome (which is also met through a diagnosis of Alzheimer's Dementia)
  3. * Agreement to participate in study and able to complete informed consent process
  4. * Have a caregiver/study partner who can accompany them to all study visits
  5. * Have a known alternate surrogate decision-maker (in case needed) who can accompany them to the informed consent visit (this person may be the study partner mentioned above)
  6. * Screening MMSE score of 18-26
  7. * Screening GDS score \<6
  8. * Either 1) treated with memory-enhancing medication (cholinesterase inhibitor) for at least 2 months, 2) failed trial with no plan to re-trial, or 3) no trial planned during the course of the study for other reasons
  9. * No change in use of psychotropic medication for the treatment of depression, anxiety, ADHD, or psychosis for 2 weeks prior to the study
  1. * Participant and/or their surrogate are unwilling or unable to provide informed consent
  2. * Currently pregnant or potentially pregnant
  3. * Diagnosis of a dementia or cognitive disorder due to a cause other than Alzheimer's Disease
  4. * Diagnosis of severe Dementia (CDR \> 2.0) at the start of the study
  5. * History of substance use disorder currently not in sustained remission
  6. * Substance misuse within the past 6 months (excluding nicotine or caffeine)
  7. * History of stroke, traumatic brain injury with loss of consciousness, or other major neurologic disorder (e.g., epilepsy, Huntington's disease, Parkinson's disease)
  8. * History of seizure disorder or family history of seizure disorder in a first-degree relative
  9. * Poorly-controlled hypertension, cardiovascular disease, or cerebrovascular disease
  10. * History of any other major active medical, neurologic, or psychiatric illness affecting cognition (associated with cognitive impairment) or a participant's ability to safely and meaningfully participate in the study
  11. * Non-fluent in English (not native or functionally-native)
  12. * Contraindication to TMS or MRI including claustrophobia, MRI-incompatible or unknown metal in body (including facial tattoos with uknown or metallic inks), surgery within 60 days, certain implants (excluding dental fillings), or previous abnormal MRI results.
  13. * Has previous history of TMS treatment in the past (not TMS naïve)
  14. * Currently enrolled in a memory-enhancement study
  15. * Alteration in cognitive-enhancement medication dose within the past 2 months or active plans for dose alteration during the course of the study (previously unplanned changes that occur during the study will be examined on a case-by-case basis)
  16. * History of treatment with lecanemab, aducanumab, donanemab, or other monoclonal antibody treatment for Alzheimer's Disease (due to lack of knowledge surrounding the impacts of these treatments)
  17. * Currently or within the past 2 weeks taking any of the following classes of medication:
  18. * Anticholinergic (e.g., tolterodine, benztropine)
  19. * Sedating antihistamines (e.g., diphenhydramine)
  20. * any drug that has significant anticholinergic or antihistaminic side effects (e.g., tricyclic antidepressant medications, mirtazapine).
  21. * Benzodiazepines. While not a strict rule out, this will be decided on a case-by-case basis
  22. * Antiepileptic agents. While not a strict rule out, this will be decided on a case-by-case basis
  23. * Antipsychotic agents. While not a strict rule out, this will be decided on a case-by-case basis

Contacts and Locations

Study Contact

Cole Mathews
CONTACT
(310) 825-7797
TMSResearch@mednet.ucla.edu
Michael Leuchter, MD
CONTACT
(310) 794-2312
TMSResearch@mednet.ucla.edu

Principal Investigator

Michael Leuchter, MD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

UCLA TMS Clinical and Research Service
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Michael Leuchter, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-17
Study Completion Date2026-10

Study Record Updates

Study Start Date2024-10-17
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Clinical Trial
  • deep repetitive transcranial magnetic stimulation (deep rTMS)
  • precuneus
  • Mild-to-Moderate Probable Alzheimer's Dementia

Additional Relevant MeSH Terms

  • Alzheimer's Disease
  • Alzheimer Disease
  • Dementia Alzheimer Type
  • Mild Alzheimer's Disease
  • Moderate Alzheimer's Disease
  • Alzheimer's Disease (AD)
  • Alzheimer's Dementia