Clinical trial for Alzheimer&Amp;Amp;#39;s Disease
Official title Large-coil Parietal Repetitive Transcranial Magnetic Stimulation (rTMS) 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 large-coil (or "deep") repetitive transcranial magnetic stimulation (rTMS) targeting the precuneus and surrounding areas is feasible, tolerable, and potentially efficacious for memory in Alzheimer's Disease. 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 55 to 100
You may be able to join if
- Agreement to participate in study and able to complete informed consent process
- Have a caregiver or study partner who can accompany them to all study visits
- Have a known alternate surrogate decision-maker (in case needed) who can be present for informed consent
- Established diagnosis of biomarker-positive (amyloid-PET, plasma or CSF amyloid ratio or phosphorylated tau) mild-moderate (clinical stages 3, 4, and...
- Age 55-100 at the start of the study.
You likely can't join if
- Unwilling or unable to provide informed consent as outlined below
- Currently pregnant or potentially pregnant
- Diagnosis of a dementia or cognitive disorder primarily or exclusively due to a cause other than Alzheimer's Disease
- Diagnosis of severe Dementia (CDR \> 2.0/ AA clinical stage 6) 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
- Agreement to participate in study and able to complete informed consent process
- Have a caregiver or study partner who can accompany them to all study visits
- Have a known alternate surrogate decision-maker (in case needed) who can be present for informed consent
- Established diagnosis of biomarker-positive (amyloid-PET, plasma or CSF amyloid ratio or phosphorylated tau) mild-moderate (clinical stages 3, 4, and 5) Alzheimer's Disease based on the 2024 Alzheimer's Association...
- Age 55-100 at the start of the study.
- Screening MOCA 12-25 (\ 11)
- Screening GDS score \<6
- Either 1) treated with memory-enhancing medication (cholinesterase inhibitor or other medications or treatments) for at least 2 months, 2) failed trial with no plan to re-trial, or 3) no trial planned during the course...
- No change in use of psychotropic medication (or other treatments) for the treatment of depression, anxiety, ADHD, or psychosis for 2 weeks prior to the study
What rules you out
- Unwilling or unable to provide informed consent as outlined below
- Currently pregnant or potentially pregnant
- Diagnosis of a dementia or cognitive disorder primarily or exclusively due to a cause other than Alzheimer's Disease
- Diagnosis of severe Dementia (CDR \> 2.0/ AA clinical stage 6) 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, specified here for cognitive testing purposes)
- 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...
- For the assigned by chance stage only-has a history of prior TMS treatment (not TMS naïve)
- Currently enrolled in an treatment memory-enhancement study
- Alteration in cognitive-enhancement medication (or other treatment) 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...
- Has started treatment with lecanemab, donanemab, or any other monoclonal antibody for Alzheimer's Disease within the past 6 months OR has a history of treatment complicated by amyloid-related imaging abnormalities (ARIA)
- 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
- Opioid. 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, 55 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.