Use of [123I] AV39 and SPECT Imaging as a Marker of Protein Disposition in Subjects With Alzheimer Disease Compared to Healthy Subjects
Evaluation of [123I] AV39 and SPECT as a Marker of Beta-Amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
調査の概要
詳細な説明
Approximately 20 patients with Alzheimer's disease (AD) and 10 healthy controls will be recruited to participate in this study. Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline.
All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations.
Subjects will be asked to undergo a bolus injection of 123-I AV39. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I AV39 in plasma (both protein bound and free) over a period of up to 6 hours.
Subjects may be asked to undergo a second imaging visit between 2 and 6 weeks following the initial imaging visit following similar procedures to the initial imaging visit to evaluate the reproducibility of the imaging measure using this procedure. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition.
The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I AV39. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the AD patients and controls will be compared.
For those subjects undergoing repeat imaging visits, the data from the initial scan will be compared to the second scan to determine which offers the reproducibility of the imaging outcome measure.
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究場所
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Connecticut
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New Haven、Connecticut、アメリカ、06510
- Molecular NeuroImaging, LLC
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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
説明
Inclusion Criteria:
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
- Mini-Mental Status Exam score < 25.
- Modified Hachinski Ischemia Scale score of ≤ 4.
- Geriatric Depression Scales (GDS) ≤ 10.
- For females, non-child bearing potential or negative urine or blood pregnancy test on day of 123-I AV39 injection.
Exclusion Criteria:
- The subject has signs or symptoms of another neurodegenerative disease including Parkinson's disease, diffuse Lewy body dementia, or 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 any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- 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:非ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:独身
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 |
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Assess the dynamic uptake and washout of 123-I AV39
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二次結果の測定
結果測定 |
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Blood metabolite characterization of 123-I AV39 in healthy and AD subjects to determine the metabolic fate and nature of metabolites
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Evaluate the test/retest reproducibility of 123-I AV39 and SPECT in AD subjects and healthy controls
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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
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
アルツハイマー病の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
[123I] AV 39の臨床試験
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Institute for Neurodegenerative Disorders終了しました多発性硬化症 | パーキンソン病 | アルツハイマー病 | 健康管理アメリカ
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Institute for Neurodegenerative Disorders終了しました
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Institute for Neurodegenerative DisordersUnited States Department of Defense; Molecular NeuroImaging積極的、募集していない
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Molecular NeuroImaging終了しました
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Molecular Insight Pharmaceuticals, Inc.National Cancer Institute (NCI)引きこもった
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GE HealthcarePPD完了中国人患者におけるパーキンソン症候群 (PS) の診断のための単一光子放出コンピューター断層撮影法 (SPECT) における DaTSCAN™ イオフルパン (123I) 注射の診断効果を評価する研究本態性振戦 | 多系統萎縮症(MSA) | パーキンソン症候群 | パーキンソン病(PD) | 進行性核上性麻痺(PSP)中国
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Institute for Neurodegenerative DisordersUnited States Department of Defense; Molecular NeuroImaging完了
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Institute for Neurodegenerative DisordersUnited States Department of Defense; Molecular NeuroImaging完了
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Institute for Neurodegenerative DisordersUnited States Department of Defense完了