Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597942
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Deep Repetitive Transcranial Magnetic Stimulation rTMS of the Precuneus for Alzheimer Disease AD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Protocol for Maintaining and Improving Mental Status in Alzheimers Disease PROMIS-AD a Pilot Study of Repetitive Transcranial Magnetic Stimulation of the Precuneus for Alzheimerampamp39s Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMIS-AD
Brief Summary:
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 Alzheimers Dementia Previous work studying rTMS in Alzheimers 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 Alzheimers
Are there signs of positive brain changes in response to deep rTMS
Is deep rTMS potentially efficacious for memory in Alzheimers 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 Alzheimers 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
Is deep rTMS of the precuneus feasible and tolerable in Alzheimers
Are there signs of positive brain changes in response to deep rTMS
Is deep rTMS potentially efficacious for memory in Alzheimers 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 Alzheimers 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
Detailed Description:
This study is designed to examine whether non-invasive electromagnetic stimulation of a specific brain region can help improve memory in the short-term in Alzheimers Disease AD AD is a progressive neurodegenerative disease that affects multiple domains including cognitive eg memory executive function behavioral eg wandering difficulty controlling impulses irritability emotional eg anxiety depression and functional eg ability to live independently and complete activities of daily living domains It is also associated with increased caregiver burden which can adversely affect caregivers health
One increasingly apparent contributor to disease progression in AD is brain network dysregulation particularly within the default mode network Repetitive transcranial magnetic stimulation rTMS is a noninvasive therapeutic modality that can be used to stimulate the precuneus a key node in the default mode network and maintain signaling function within the default mode network Previous studies have shown that targeting the precuneus with rTMS may enhance memory in the short term and delay disease progression and functional decline in AD over longer periods rTMS protocols that have demonstrated promise for treatment delay have first shown short-term impacts on memory particularly memory of recent and past events
We will conduct a two-phase trial of rTMS targeting the precuneus in patients with mild to moderate probable AD focused primarily on determining safety and feasibility and secondarily focused on determining short-term efficacy for memory Participants will be recruited through fliers social media print and web advertising as well as referrals from other UCLA studies UCLA clinics and known community clinics The first phase will be a handful of subjects 5-10 receiving active treatment only to refine the protocol After refinement the second phase will consist of a randomized double-blind sham controlled clinical trial with post-blinding crossover examining both safety and short-term efficacy for memory Participants will be randomized on a 11 ratio to either receive precuneus or sham rTMS
Participants will undergo 16 total rTMS brain stimulation sessions each session being about 20 minutes over the course of 5 weeks The initial induction 3-day intensive course in which rTMS or sham will be applied four times daily with 1-hour breaks between treatments will be followed by a 4-week maintenance course in which stimulation will be applied once weekly
Participants will undergo a range of assessments including brain imaging and oxygenation genotyping eye reactivity to light testing and brain electrical activity measurements to identify changes that occur in the precuneus and its connected regions over time Participants will also undergo comprehensive neuropsychological memory and behavioral testing at baseline and during follow up Additionally participants and their caregivers will complete brief weekly check-ins at each treatment during the study
One increasingly apparent contributor to disease progression in AD is brain network dysregulation particularly within the default mode network Repetitive transcranial magnetic stimulation rTMS is a noninvasive therapeutic modality that can be used to stimulate the precuneus a key node in the default mode network and maintain signaling function within the default mode network Previous studies have shown that targeting the precuneus with rTMS may enhance memory in the short term and delay disease progression and functional decline in AD over longer periods rTMS protocols that have demonstrated promise for treatment delay have first shown short-term impacts on memory particularly memory of recent and past events
We will conduct a two-phase trial of rTMS targeting the precuneus in patients with mild to moderate probable AD focused primarily on determining safety and feasibility and secondarily focused on determining short-term efficacy for memory Participants will be recruited through fliers social media print and web advertising as well as referrals from other UCLA studies UCLA clinics and known community clinics The first phase will be a handful of subjects 5-10 receiving active treatment only to refine the protocol After refinement the second phase will consist of a randomized double-blind sham controlled clinical trial with post-blinding crossover examining both safety and short-term efficacy for memory Participants will be randomized on a 11 ratio to either receive precuneus or sham rTMS
Participants will undergo 16 total rTMS brain stimulation sessions each session being about 20 minutes over the course of 5 weeks The initial induction 3-day intensive course in which rTMS or sham will be applied four times daily with 1-hour breaks between treatments will be followed by a 4-week maintenance course in which stimulation will be applied once weekly
Participants will undergo a range of assessments including brain imaging and oxygenation genotyping eye reactivity to light testing and brain electrical activity measurements to identify changes that occur in the precuneus and its connected regions over time Participants will also undergo comprehensive neuropsychological memory and behavioral testing at baseline and during follow up Additionally participants and their caregivers will complete brief weekly check-ins at each treatment during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None