Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological Conditions (PBR06)
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (予想される)
入学
段階
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Connecticut
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New Haven、Connecticut、アメリカ、06510
- Institute for Neurodegenerative Disorders
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参加基準
適格基準
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
説明
Inclusion Criteria:
The following criteria will be met for inclusion of AD subjects in this study:
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of probable Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
- Clinical Dementia Rating Scale score ≤ 2.
- Modified Hachinski Ischemia Scale score of ≤ 4.
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-PBR06 injection.
The following criteria will be met for inclusion of PD subjects in this study:
- The participant is 30 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of Parkinson disease (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia).
- Hoehn and Yahr ≤4.
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-PBR06 injection.
The following criteria will be met for inclusion of MS subjects in this study:
- The participant is 18 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of Multiple Sclerosis (per the 2005 Revised McDonald Criteria; Polman, et al., 2005).
- Kurtzke Expanded Disability Status Scale (EDSS) ≤ 7.5.
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-PBR06 injection
The following criteria will be met for inclusion of healthy control subjects in this study:
- The participant is 18 years or older.
- Written informed consent is obtained.
- Negative history of neurological or psychiatric illness based on evaluation by a research physician.
- Clinical Dementia Rating score = 0.
- For females, non-child bearing potential a negative urine or blood pregnancy test on day of [18F]-PBR06 injection.
Exclusion Criteria:
Alzheimer's subjects will be excluded from participation for the following reasons:
- The subject has a history of significant cerebrovascular disease.
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
Parkinson's subjects will be excluded from participation for the following reasons:
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
MS subjects will be excluded from participation for the following reasons:
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
Healthy control subjects will be excluded from participation for the following reasons:
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
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
- 主な目的:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的:Assess [18F] PBR06 and PET imaging
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Subjects will be injected with 5mCi, not to exceed >10% of 5mCI, of [18F]PBR06, followed by PET imaging.
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この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
To evaluate [18F] PBR06 PET imaging as a tool to detect microglial activation in the brain of AD, PD and MS research participants.
時間枠:1 year
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1 year
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協力者と研究者
研究記録日
主要日程の研究
研究開始
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- PBR06 001
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