遅発性精神病（LOP）におけるタウバイオマーカー
Hallucinations or delusions that occur for the first time in older people with no acute medical problems or mood symptoms may be related to impending dementia. This study aims to confirm this hypothesis using novel blood biomarkers and Positron Emission Tomography (PET) imaging tracers, as well as non-invasive testing.
調査の概要
詳細な説明
Psychotic symptoms that occur in advanced age in the absence of an acute medical condition or prominent mood symptoms can represent the late appearance of primary psychotic disorders such as very late-onset schizophrenia-like psychosis (VLOSP) or delusional disorder, or can presage the appearance of a neurodegenerative condition such as Alzheimer's disease (AD). An episode of non-affective psychosis late in life more than doubles the risk of subsequent neurodegenerative disease, with an average time from psychosis to AD diagnosis of 18 months. The biologic mechanisms responsible for the increased risk of dementia in those who experience psychosis are unclear. One hypothesis is reverse causality, in which inchoate neurodegeneration is responsible for psychotic symptoms that emerge in the absence of traditional cognitive hallmarks of dementia. The psychosis then heralds the inception of illness that will eventuate in cognitive decline. The investigators will utilize neurodegenerative biomarkers in the form of novel PET imaging tracers, plasma immunoassays and non-invasive neurophysiologic measurements to test this hypothesis in a pilot cohort of elderly subjects suffering with psychosis occurring in late-life without dementia for comparison with a cohort of healthy elderly controls (HEC)s who are participating in a study focused on those with dementia.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Erica Christen, MS
- 電話番号：516-562-3492
- メール：EChriste@northwell.edu
研究連絡先のバックアップ
- 名前：Nichole Hoehn, MS
- 電話番号：516-562-3492
- メール：nhoehn@northwell.edu
研究場所
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New York
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Manhasset、New York、アメリカ、11030
- 募集
- The Feinstein Institutes for Medical Research
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コンタクト：
- Erica Christen, MS
- 電話番号：516-562-3492
- メール：EChriste@northwell.edu
-
コンタクト：
- Michelle Gong, AS
- 電話番号：516-562-3492
- メール：MGong@northwell.edu
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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
サンプリング方法
調査対象母集団
Very late-onset schizophrenia-like psychosis (VLSOP) diagnostic criteria:
VLSOP is a schizophrenia-like condition characterized by the onset of delusions (primarily persecutory but also bizarre delusions) and/or hallucinations (auditory, visual, tactile, or olfactory) after age 60 in the absence of negative symptoms, formal thought disorder, and affective flattening that are common in early-onset schizophrenia.
Delusional disorder diagnostic criteria:
Delusional disorder comprises the presences of non-bizarre delusions including erotomanic, grandiose, jealous, persecutory, or somatic subtypes.
The presence of one (or more) above delusions with a duration of 1 month or longer.
説明
Inclusion Criteria:
- Male or female, aged 65-85 years.
- Diagnosis of late-onset non-affective primary psychotic disorder consistent with either very late-onset schizophrenia-like psychosis (VLOSP, International Late-Onset Schizophrenia Group consensus criteria, Howard et al., 2000) or delusional disorder (DSM-5 criteria)
- Caregiver available to provide collateral history and participation in informant-based ratings (NPI,CDR)
- Clinical Dementia Rating (CDR) score of 0 or 0.5.
- Mini-Mental State Examination (MMSE) score ≥ 24 and at the screening visit.
- Normal memory function (to rule-out mild cognitive impairment, MCI) documented by scoring within 1.5 SD range in education adjusted norms of the Logical Memory II subscale
- Ability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation (hearing aids permitted).
Exclusion Criteria:
- Participants with affective and psychotic disorders including bipolar disorder, schizoaffective disorder, active major depression; insulin dependent type 2 diabetes; a history of CVD; a history of epilepsy; a history of TBI with greater than 15 minutes of loss of consciousness; a movement disorder including Parkinson's disease; stroke; autoimmune disease affecting the CNS; substance abuse disorder; or active delirium/encephalopathy.
- Evidence of a clinically relevant neurological disorder
- Modified Hachinski ischemia score of more than 4.
- History of alcoholism or drug dependency/abuse within the last 5 years before screening.
- Presence of metal implants such as pacemakers, ear implants, internal bullet fragments or shrapnel.
- Inability to lie flat for 1 hour approximately.
- Hearing impairment as evidenced by the inability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation. Subjects with hearing aids will be allowed to participate if they meet minimum hearing 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
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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Quantification of neurofibrillary tangle pathology in subjects via PET [18F]PI-2620 radiotracer uptake.
時間枠：Each subject will have one PET imaging scan at visit 3 (week 4).
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To determine whether there are increases in tau pathology in those with psychotic episodes that occur late in life employing tau PET ligands, and whether those increases are etiologic contributors to a stable psychosis or are a presage of an incipient cognitive decline. |
Each subject will have one PET imaging scan at visit 3 (week 4).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measurement of peripheral soluble tau pathology with tau plasma immunoassays.
時間枠：Each subject will have blood collected at visit 1 or 2 (week 1 or 2).
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Plasma samples will be collected via venipuncture from LOP subjects and batch shipped to Quanterix Inc. for ptau analyses and quantification on the SiMOA SR-X analyzer platform. |
Each subject will have blood collected at visit 1 or 2 (week 1 or 2).
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluation of sensorimotor gating integrity and it's association to tau PET ligand uptake.
時間枠：Each subject will participate in this assessment at visit 2 (week 2).
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Prepulse Inhibition of Acoustic Startle (PPI) sessions will be assessed using eyeblink response (electromyography of the orbicularis oculi muscle) to a 115-dB startle stimulus. |
Each subject will participate in this assessment at visit 2 (week 2).
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Jeremy Koppel, MD、Northwell Health
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
追加の関連 MeSH 用語
その他の研究ID番号
- 23-0874
- 1R21MH135148 (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
Raw imaging files and neurocognitive data will be made available to other researchers via the NIMH Data Repository. Demographic data including age, sex, ethnicity and diagnosis will be shared. Information needed to generate a global unique identifier for the NIMH Data Archive (NDA) will be collected for each subject. In addition to the subject level data described above, all PET and MRI designs and experiment definitions, and study protocols will be deposited in the NDA.
IPD 共有時間枠
Data will be made available as soon as possible or at the time of associated publication, whichever comes first.
IPD 共有アクセス基準
To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- CSR
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。