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Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease

11. října 2022 aktualizováno: Pfizer

A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE DOSES OF PF 04360365 IN PATIENTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE.

Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient with mild to moderate Alzheimer's disease.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

198

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Austrálie
    • South Australia
      • Adelaide, South Australia, Austrálie, 5000
        • Royal Adelaide Hospital
      • Woodville South, South Australia, Austrálie, 5011
        • The Queen Elizabeth Hospital and Health Service
    • Victoria
      • Heidelberg West, Victoria, Austrálie, 3084
        • Heidelberg Repatriation Hospital, Austin Health
    • Western Australia
      • Nedlands, Western Australia, Austrálie, 6009
        • The McCusker Foundation for Alzheimer's Disease Research
  • Belgie
      • Antwerpen, Belgie, 2020
        • ZNA Middelheim / Neurology
      • Edegem, Belgie, 2650
        • UZ Antwerpen, Department of Neurology
      • Jette, Belgie, 1090
        • UZ Brussel / Geriatrie
      • Leuven, Belgie, 3000
        • U.Z. Gasthuisberg / Neurologie
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6T 2B5
        • University of British Columbia Hospital, Division of Neurology
    • Ontario
      • London, Ontario, Kanada, N6C 5J1
        • Parkwood Hospital, Geriatric Medicine
      • Peterborough, Ontario, Kanada, K9H 2P4
        • Kawartha Regional Memory Clinic
      • Toronto, Ontario, Kanada, M4N 3M5
        • SunnyBrook Health Sciences Centre
      • Toronto, Ontario, Kanada, M3B 2S7
        • Toronto Memory Program
    • Quebec
      • Montreal, Quebec, Kanada, H1T 2M4
        • Recherche Clinique de Neurologie
      • Sherbrooke, Quebec, Kanada, J1H 1Z1
        • Diex Recherche Inc.
  • Korejská republika
      • Seoul, Korejská republika, 135-710
        • Samsung Medical Center
      • Seoul, Korejská republika, 138-736
        • Asan Medical Center
      • Seoul, Korejská republika, 136-705
        • Korea University Anam Hospital
      • Seoul, Korejská republika, 133-792
        • Hanyang University Hospital
      • Seoul, Korejská republika, 143-914
        • Konkuk University Medical Center
    • Gyeonggi
      • Seongnam, Gyeonggi, Korejská republika, 463-707
        • Seoul National University Bundang Hospital
  • Spojené království
      • Manchester, Spojené království, M50 2GY
        • MAC UK Neuroscience Ltd
      • Southampton, Spojené království, SO30 3JB
        • Memory Assessment and Research Centre
      • Southampton, Spojené království, SO16 6YD
        • Wellcome Trust Clinical Research Facility
    • Chesire
      • Cheadle, Chesire, Spojené království, SK8 2PX
        • The Pharmacy Department
    • Wiltshire
      • Swindon, Wiltshire, Spojené království, SN3 6BB
        • The Shalbourne Suite
      • Swindon, Wiltshire, Spojené království, SN3 6BW
        • Kingshill Research Centre
  • Spojené státy
    • Arizona
      • Peoria, Arizona, Spojené státy, 85381
        • Pivotal Research Center
      • Peoria, Arizona, Spojené státy, 85381
        • Sun Radiology- for MRI
      • Phoenix, Arizona, Spojené státy, 85013
        • Dedicated Phase 1
    • Florida
      • Miami, Florida, Spojené státy, 33176
        • Neuroscience Consultants, LLC
      • South Miami, Florida, Spojené státy, 33143
        • Miami Research Associates
      • South Miami, Florida, Spojené státy, 33143
        • MRA Clinical Research
      • South Miami, Florida, Spojené státy, 33143
        • Sleep Florida, LLC
    • Illinois
      • Elk Grove Village, Illinois, Spojené státy, 60007
        • Alexian Brothers Medical Center
      • Elk Grove Village, Illinois, Spojené státy, 60007
        • Alexian Brothers Neurosciences Institute
    • Kansas
      • Overland Park, Kansas, Spojené státy, 66212
        • Vince and Associates Clinical Research
      • Overland Park, Kansas, Spojené státy, 66209
        • Stark Pharmacy
      • Overland Park, Kansas, Spojené státy, 66211
        • Vince and Associates Clinical Research
    • New Jersey
      • Eatontown, New Jersey, Spojené státy, 07724
        • Memory Enhancement Center of America, Inc
      • Oakhurst, New Jersey, Spojené státy, 07755
        • Central Jersey Radiology
    • Rhode Island
      • Providence, Rhode Island, Spojené státy, 02906
        • Butler Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

50 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Males or females of non childbearing potential, age > or = 50

  • Diagnosis of probable Alzheimer's disease, consistent with criterial from both:

    • National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
    • Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
  • Mini-mental status exam score of 16-26 inclusive
  • Rosen-Modified Hachinski Ischemia Score of < or = 4

Exclusion Criteria:

  • Diagnosis or history of other demential or neurodegenerative disorders
  • Diagnosis or history of clinically significant cerebrovascular disease
  • Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities
  • History of autoimmune disorders
  • History of allergic or anaphylactic reactions

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo
Lék: Placebo
Placebo every 60 days (10 doses total)
Experimentální: PF-04360365 8.5 mg/kg
Biologický: PF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days (10 doses total)
Experimentální: PF-04360365 1 mg/kg
Biologický: PF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)
Experimentální: PF-04360365 3 mg/kg
Biologický: PF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)
Experimentální: PF-04360365 0.1 mg/kg
Biologický: PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)
Experimentální: PF-04360365 0.5 mg/kg
Biologický: PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Časové okno: Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study medication and up to 6 months after last dose that were absent before treatment or worsened relative to pre-treatment state.
Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
Časové okno: Baseline up to Month 24
Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral/meningeal enhancement, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyperintensities) were assessed from structural MRI. Participants with brain abnormality other than those listed above, assessed using MRI scan, were reported under other abnormality. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline up to Month 24
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
Časové okno: Baseline up to Month 24
Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline up to Month 24
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
Časové okno: 0 Hour on Day 0
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour on Day 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
Časové okno: 0 Hour (pre-dose) on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 1
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1
Časové okno: 2 Hours on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 1
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60
Časové okno: 0 Hour (pre-dose) on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 60
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60
Časové okno: 2 Hours on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 60
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90
Časové okno: Day 90
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 90
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120
Časové okno: 0 Hour (pre-dose) on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 120
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120
Časové okno: 2 Hours on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 120
Mean Plasma Concentration of PF-04360365 on Day 150
Časové okno: Day 150
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 150
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180
Časové okno: 0 Hour (pre-dose) on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 180
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180
Časové okno: 2 Hours on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 180
Mean Plasma Concentration of PF-04360365 on Day 210
Časové okno: Day 210
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 210
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240
Časové okno: 0 Hour (pre-dose) on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 240
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240
Časové okno: 2 Hours on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 240
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300
Časové okno: 0 Hour (pre-dose) on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 300
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300
Časové okno: 2 Hours on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 300
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360
Časové okno: 0 Hour (pre-dose) on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 360
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360
Časové okno: 2 Hours on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 360
Mean Plasma Concentration of PF-04360365 on Day 390
Časové okno: Day 390
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 390
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420
Časové okno: 0 Hour (pre-dose) on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 420
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420
Časové okno: 2 Hours on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 420
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480
Časové okno: 0 Hour (pre-dose) on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 480
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480
Časové okno: 2 Hours on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 480
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540
Časové okno: 0 Hour (pre-dose) on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 540
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540
Časové okno: 2 Hours on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 540
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570
Časové okno: Day 570
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 570
Mean Plasma Concentration of PF-04360365 on Day 660
Časové okno: Day 660
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 660
Mean Plasma Concentration of PF-04360365 on Day 720
Časové okno: Day 720
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 720

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
Časové okno: Baseline
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19
Časové okno: Baseline and Month 19
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline and Month 19
Disability Assessment for Dementia (DAD) Score at Baseline
Časové okno: Baseline
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline
Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19
Časové okno: Baseline and Month 19
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline and Month 19
Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)
Časové okno: 0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)
Časové okno: 0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)
Časové okno: 0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Results are not reported for PF-04360365 0.1, 0.5, 1.0 mg/kg, Placebo (Part A and B) arms because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)
Časové okno: Day 0 (Hour 0), 90, 570
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)
Časové okno: Day 0 (Hour 0), 90, 570
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)
Časové okno: Day 0 (Hour 0), 90, 570
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
Časové okno: Day 0 (Hour 0), 90, 570
Day 0 (Hour 0), 90, 570
Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
Časové okno: Baseline up to Month 24
Abnormality was defined as concentration either less than lower limit of normal (LLN) or more than upper limit of normal (ULN). Baseline was defined as the last assessment prior to the first study drug infusion
Baseline up to Month 24
Number of Participants With Serum Anti-Drug Anti Body (ADA)
Časové okno: Day 1 up to Month 24
Serum samples were analyzed for the presence or absence of anti-PF-04360365 antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA). Only participants receiving PF-04360365 were analyzed for this outcome measure.
Day 1 up to Month 24

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

5. prosince 2008

Primární dokončení (Aktuální)

16. srpna 2011

Dokončení studie (Aktuální)

16. srpna 2011

Termíny zápisu do studia

První předloženo

23. července 2008

První předloženo, které splnilo kritéria kontroly kvality

24. července 2008

První zveřejněno (Odhad)

25. července 2008

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. listopadu 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. října 2022

Naposledy ověřeno

1. října 2022

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • A9951002
  • 2008-000986-42 (Číslo EudraCT)
  • MD IN AD PATIENT (Jiný identifikátor: Alias Study Number)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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