Effects of Adolescent Synaptic Pruning (SPA PET)
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- Laboratory of Neurocognitive Development
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Males or females between 18-26 years of age, AND currently enrolled in the Parent Project (R01MH067924)
Exclusion Criteria: (these exclusion criteria are outlined in the Parent Project)
- Head injury with loss of consciousness over an hour.
- A vision problem or eye movement problem (such as lazy eye, double vision, blurred vision, or color blindness).
- A learning disability and/or ever had an Individualized Education Plan (IEP) in school.
- Significant neurological or metabolic illness: Epilepsy, Meningitis, Encephalitis, Diabetes, Huntington's disease.
- Diagnosed with a psychiatric disorder.
- Participants with, or with a first degree relative, having a DSM IV Axis l psychiatricdisorder.
- Metal implants or ferromagnetic objects contained within the body which may interfere with the MRI scan (but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.) Dental fillings do not present a risk for MRI. If there is a possibility of metal being present in the participant's body, the participant will be excluded from the study.
- Weight more than 250 pounds.
- Claustrophobia or uncomfortable in small spaces.
- <70% on the Achenbach scale (either from Youth Self Report (YSR) or Adult Self Report (ASR)).
- IQ < 80 or IQ > 130.
- Pregnancy or lactation, lack of effective birth control during 15 days before the scans.
- Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous radioactive drug study [studies] and this study) would exceed the radiation dose limits specified in the FDA regulations (i.e., 21 CFR 361.1) that govern the research use of [C-11]UCB-J
- History of drug or alcohol abuse (from parent study eligibility).
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:基礎科学
- 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)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:PET Imaging Supplemental Component
Adult participants enrolled in the parent study, will be given the option to be a part of the PET imaging supplemental project.
Maximum enrollment is 60 adult participants.
Interested participants will be consented into the PET portion, and will have a single PET scan (as outlined in the Study Description section).
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[11C]UCB-J (~ 15 mCi and ≤ 6μg) will be injected as a slow intravenous bolus.
Following an intravenous bolus injection of [11C]UCB-J, the participants will be positioned in the scanner for a low dose CT scan (for attenuation correction) fifty-five minutes after the [11C]UCB-J injection, and emission data will be collected.
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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
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Non-invasive quantification of synaptic pruning
時間枠:The PET-CT scan will be within approximately 30 days of the parent study MRI.
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1. Age-related changes in synaptic density through young adulthood o Cross-sectional age-related (18-26 years of age) changes in synaptic density via SUVR quantified within the dorsolateral prefrontal cortex. |
The PET-CT scan will be within approximately 30 days of the parent study MRI.
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Non-invasive quantification of synaptic pruning
時間枠:The PET-CT scan will be within approximately 30 days of the parent study MRI.
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2. Within-subject associations of synapse density to MRI-derived measures of brain membrane byproducts o Synaptic density, based on SUVR modeling of [11C]UCB-J acquisitions, will be compared to ultra-high field (7 Tesla) [31P]MRSI measurement of membrane phospholipid levels obtained from the same participants. |
The PET-CT scan will be within approximately 30 days of the parent study MRI.
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Beatriz Luna, PhD、University of Pittsburgh
研究記録日
主要日程の研究
研究開始 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY24060023
- 3R01MH067924-19S1 (米国 NIH グラント/契約)
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
PET Imaging Scan using [11C]UCB-Jの臨床試験
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Universitaire Ziekenhuizen KU LeuvenCHDI Foundation, Inc.募集
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Alkermes, Inc.University Medical Center Groningen; Amsterdam UMC, location VUmc; QPS Netherlands B.V.完了
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Yale UniversityNational Center for Complementary and Integrative Health (NCCIH)完了
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Centre Hospitalier St AnneRoche Pharma AG募集
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Yale UniversityNational Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)積極的、募集していない