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New treatment option for Alzheimer&Amp;Amp;#39;s Disease
Official title Deep Repetitive Transcranial Magnetic Stimulation (rTMS) of the Precuneus for Alzheimer Disease (AD)
ClinicalTrials.gov ID: NCT06597942
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 100
You may be able to join if
- Age 60-100 at the start of the study
- Established diagnosis of Alzheimer's Clinical Syndrome (which is also met through a diagnosis of Alzheimer's Dementia)
- Agreement to participate in study and able to complete informed consent process
- Have a caregiver/study partner who can accompany them to all study visits
- 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...
You likely can't join if
- Participant and/or their surrogate are unwilling or unable to provide informed consent
- Currently pregnant or potentially pregnant
- Diagnosis of a dementia or cognitive disorder due to a cause other than Alzheimer's Disease
- Diagnosis of severe Dementia (CDR \> 2.0) at the start of the study
- History of substance use disorder currently not in sustained remission
- Substance misuse within the past 6 months (excluding nicotine or caffeine)
See the full eligibility criteria
Who can join
- Age 60-100 at the start of the study
- Established diagnosis of Alzheimer's Clinical Syndrome (which is also met through a diagnosis of Alzheimer's Dementia)
- Agreement to participate in study and able to complete informed consent process
- Have a caregiver/study partner who can accompany them to all study visits
- 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)
- Screening MMSE score of 18-26
- Screening GDS score \<6
- 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
- No change in use of psychotropic medication for the treatment of depression, anxiety, ADHD, or psychosis for 2 weeks prior to the study
What rules you out
- Participant and/or their surrogate are unwilling or unable to provide informed consent
- Currently pregnant or potentially pregnant
- Diagnosis of a dementia or cognitive disorder due to a cause other than Alzheimer's Disease
- Diagnosis of severe Dementia (CDR \> 2.0) at the start of the study
- History of substance use disorder currently not in sustained remission
- Substance misuse within the past 6 months (excluding nicotine or caffeine)
- History of stroke, traumatic brain injury with loss of consciousness, or other major neurologic disorder (e.g., epilepsy, Huntington's disease, Parkinson's disease)
- History of seizure disorder or family history of seizure disorder in a first-degree relative
- Poorly-controlled hypertension, cardiovascular disease, or cerebrovascular disease
- 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
- Non-fluent in English (not native or functionally-native)
- 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...
- Has previous history of TMS treatment in the past (not TMS naïve)
- Currently enrolled in a memory-enhancement study
- 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...
- 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)
- Currently or within the past 2 weeks taking any of the following classes of medication:
- Anticholinergic (e.g., tolterodine, benztropine)
- Sedating antihistamines (e.g., diphenhydramine)
- any drug that has significant anticholinergic or antihistaminic side effects (e.g., tricyclic antidepressant medications, mirtazapine).
- Benzodiazepines. While not a strict rule out, this will be decided on a case-by-case basis
- Antiepileptic agents. While not a strict rule out, this will be decided on a case-by-case basis
- Antipsychotic agents. While not a strict rule out, this will be decided on a case-by-case basis
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.