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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Kara Detlefsen
- 電話番号：720-656-1543
- メール：kara@sinapticatx.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients 65-85 years of age with mild (stage 4) or moderate (stage 5) AD
説明
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:
-
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.
-
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants with quality EEG recordings
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Procedural safety and device-related events
時間枠：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
時間枠：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
時間枠：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
|
|
Screening, eligibility, and enrollment feasibility
時間枠：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.
|
協力者と研究者
捜査官
- スタディチェア：Giacomo Koch, MD, PhD、Sinaptica Therapeutics, Inc.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ST-902
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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