Precuneus Mapping With Sinaptistim® (an Investigational TMS-EEG System) in Mild to Moderate AD Patients
Transcranial magnetic stimulation (TMS), electroencephalography (EEG), and combined TMS-EEG approaches have been used in human research to characterize cortical excitability and network-level neurophysiologic responses. The SinaptiStim System is an investigational integrated TMS-EEG platform designed to synchronize TMS delivery, EEG acquisition, and is intended to support standardized characterization of neurophysiologic responses and individualized mapping of stimulation parameters relevant to later therapeutic use.
The rationale for this early single-site, non-treatment study is to obtain initial clinical evidence that the investigational device can be used safely and as intended in participants with mild to moderate Alzheimer's disease (AD), can acquire EEG data of sufficient quality for the planned application, and can be implemented operationally at the clinical site with appropriate training and usability prior to launch of a larger treatment trial.
The study involves two visits, a screening visit with magnetic resonance imaging (MRI) followed by a TMS-EEG mapping visit. Participants who complete this study successfully may be invited to provide informed consent for screening and potential enrollment in a future treatment protocol. This study does not include randomization or a sham control group or therapeutic treatment.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Kara Detlefsen
- Número de telefone: 720-656-1543
- E-mail: kara@sinapticatx.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients 65-85 years of age with mild (stage 4) or moderate (stage 5) AD
Descrição
Inclusion Criteria:
- Must have a reliable study partner with at least 10 hours per week of direct or indirect contact. The study partner must be willing and able to provide informed consent, participate in the study visits and provide information for protocol-required assessments.
- Participant and study partner must each provide signed informed consent before initiation of any study-specific assessments or procedures.
- 65 to 85 years of age
- Stable non-AD medications for at least 4 weeks before signing informed consent
- If treated with a cholinesterase inhibitor for symptoms related to Alzheimer's disease, the dose must be stable for at least 12 weeks before signing informed consent.
- Documented cognitive impairment with decline in memory for more than 6 months before signing informed consent
- Clinical stage 4 or 5 Alzheimer's disease with biological confirmation
- MMSE score 18 to 26 inclusive at Screening
- Screening CDR Global Score of 0.5 to 2.0, with CDR Memory Box score of at least 0.5 plus one additional domain Box score of at least 0.5
Exclusion Criteria:
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Any contraindication to MRI required by the protocol, including non-compatible implanted metal or electronic devices, ferromagnetic intracranial or other unsafe metallic implants, severe claustrophobia not manageable per site practice, or any other condition making MRI unsafe or not feasible.
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Current participation in another interventional clinical study, or receipt of any investigational drug, biologic, or device within 3 months before signing informed consent.
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Prior treatment with an anti-amyloid monoclonal antibody for Alzheimer's disease that is:
- Less than 6 months of continuous treatment immediately before informed consent, or
- Not at a stable label-recommended maintenance dose/maximally tolerated dose, or
- Interrupted for > 8 consecutive weeks during that 6-month period, or
- Associated at any time prior to informed consent with ARIA-E or ARIA-H (including microhemorrhage, superficial siderosis, or macro hemorrhage) that resulted in temporary or permanent interruption, delay, or discontinuation of anti-amyloid monoclonal antibody treatment.
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Current use of, or plan to initiate any brain stimulation therapy before completion of this study.
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Current use of medications that may alter cortical excitability, seizure threshold, sedation, or interpretation of treatment response.
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Clinical history, laboratory findings, or neuroimaging findings consistent with any significant clinical neurodegenerative or neurologic disorder, cerebrovascular disease, structural intracranial abnormality or central nervous system lesion that may increase risk with TMS or confound study assessments.
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History of seizure disorder, epilepsy, unprovoked seizure, or any seizure considered by the investigator to indicate increased risk with TMS.
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Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study, including inability to comply with study requirements.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Observational Mild to Moderate AD Cohort
We will enroll up to 30 adults, age 65 to 85, with clinical stage 4 or 5 AD including biological confirmation. Eligible participants will have a MRI and complete a TMS-EEG mapping session. |
A non-therapeutic transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) assessment to evaluate cortical excitability and network-level brain responses.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of participants with quality EEG recordings
Prazo: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
|
Proportion of enrolled participants with successful completion of the protocol-defined device mapping procedure and acquisition of EEG data meeting predefined quality criteria |
Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Procedural safety and device-related events
Prazo: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
|
Incidence of device-related adverse events, adverse device effects, serious adverse events, and device deficiencies observed during the study visit and immediate post-procedure period. |
Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
|
|
Proportion of completed TMS-EEG mapping sessions
Prazo: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
|
Proportion of attempted sessions completed per protocol without major technical failure and with EEG data meeting predefined technical quality criteria. |
Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
|
|
Critical-task Success Ratings from Site Staff
Prazo: Study start through study closeout, approximately 6 months
|
Site staff critical-task success and structured ratings of ease of use, workflow fit, and training adequacy. This will be assessed via clinician and technician interviews using sponsor developed questionnaires and interviews. |
Study start through study closeout, approximately 6 months
|
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Screening, eligibility, and enrollment feasibility
Prazo: Study start through study closeout, approximately 6 months.
|
Number screened, number eligible, number enrolled, proportion eligible, and reasons for screen failure or non-enrollment. |
Study start through study closeout, approximately 6 months.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Giacomo Koch, MD, PhD, Sinaptica Therapeutics, Inc.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- ST-902
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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