- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00605046
Evaluation of [123I] AV151 and SPECT in Subjects w/ AD in Comparison to Healthy Subjects (AV151)
Evaluation of [123I] AV151 and SPECT as a Marker of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease (AD) in Comparison to Healthy Subjects
Purpose:
The main objectives of this proposal are as follows:
To assess the dynamic uptake and washout of 123-I AV151, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged healthy controls and Alzheimer's (AD) subjects
To perform blood metabolite characterization of 123-I AV151 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I AV151 as a single photon computed tomography (SPECT) brain imaging agent
Evaluate the test/retest reproducibility of 123-I AV151 and SPECT in AD subjects and healthy controls
Studienübersicht
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Connecticut
-
New Haven, Connecticut, Vereinigte Staaten, 06510
- Institute for Neurodegenerative Disorders
-
New Haven, Connecticut, Vereinigte Staaten, 06510
- Molecular NeuroImaging, LLC
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
INCLUSION CRITERIA: ALZHEIMER DISEASE
- 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 AV151 injection.
EXCLUSION CRITERIA: ALZHEIMER DISEASE
- 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
Concomitant therapy Patients may remain on a stable dose of anticholinesterase medication during the study. Use of donepezil (Aricept®), rivastigmine (Exelon®), galantamine (Razadyne®), tacrine (Cognex®), and memantine (Namenda®) are permitted during the study. Doses of these compounds must be stable for 2 months prior to the study. At each visit after the screening visit, the investigator will ask the patient whether any medications including OTC medications, were taken since the previous visit.
Use of antipsychotics for agitation and benzodiazepines for insomnia or anxiety is permitted. However, the use of these agents is not permitted within the 8 hours prior to administration of cognitive testing.
INCLUSION CRITERIA: HEALTHY VOLUNTEERS
- The participant is 50 years or older.
- Written informed consent is obtained.
- Negative history of neurological or psychiatric illness based on evaluation by a research physician.
- Mini-Mental Status Exam score ≥28.
- For females, non-child bearing potential or negative urine or blood pregnancy test on day of 123-I AV151 injection.
EXCLUSION CRITERIA: HEALTHY VOLUNEERS
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Asses [123I] AV151 and SPECT imaging
|
AV151-01: Evaluation of [123I] AV151 and SPECT as a marker of beta-amyloid protein deposition in subjects with Alzheimer disease in comparison to healthy subjects
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
AV151-01: Evaluation of [123I] AV151 and SPECT as a marker of beta-amyloid protein deposition in subjects with Alzheimer disease in comparison to healthy subjects
Zeitfenster: 1 year
|
1 year
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- AV151
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur SPECT scan
-
Lille Catholic UniversityRekrutierungHerzkrankheiten | Erkrankungen des Gehirns | Nierenerkrankungen | Schilddrüsenerkrankungen | KnochenerkrankungenFrankreich
-
Jeffrey A. Lieberman, MDBeendet
-
New York State Psychiatric InstituteNational Institute of Mental Health (NIMH)BeendetSchizophrenieVereinigte Staaten
-
Mayo ClinicAnmeldung auf EinladungDemenz | Leichte kognitive Einschränkung | Parkinsonismus | REM-Schlaf-VerhaltensstörungVereinigte Staaten
-
H. Lee Moffitt Cancer Center and Research InstituteAbgeschlossen
-
Royal Marsden NHS Foundation TrustUnbekanntSchilddrüsenkarzinom | Metastatische Stellen LungenknochenknotenVereinigtes Königreich
-
Peking Union Medical College HospitalRekrutierung
-
Jonsson Comprehensive Cancer CenterRekrutierungProstatakarzinom | Rezidivierendes ProstatakarzinomVereinigte Staaten
-
Molecular Insight Pharmaceuticals, Inc.AbgeschlossenProstatakrebsVereinigte Staaten, Kanada
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, nicht rekrutierendNicht resezierbares hepatozelluläres Karzinom | Hepatozelluläres Karzinom Stadium III AJCC v8 | Hepatozelluläres Karzinom im Stadium IIIA AJCC v8 | Stadium IV hepatozelluläres Karzinom AJCC v8 | Hepatozelluläres Karzinom im Stadium IVA AJCC v8 | Hepatozelluläres Karzinom im Stadium IVB AJCC... und andere BedingungenVereinigte Staaten