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

11 ottobre 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

198

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Droga: Placebo
Placebo every 60 days (10 doses total)
Sperimentale: PF-04360365 8.5 mg/kg
Biologico: PF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days (10 doses total)
Sperimentale: PF-04360365 1 mg/kg
Biologico: PF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)
Sperimentale: PF-04360365 3 mg/kg
Biologico: PF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)
Sperimentale: PF-04360365 0.1 mg/kg
Biologico: PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)
Sperimentale: PF-04360365 0.5 mg/kg
Biologico: PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Day 570
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 570
Mean Plasma Concentration of PF-04360365 on Day 660
Lasso di tempo: Day 660
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 660
Mean Plasma Concentration of PF-04360365 on Day 720
Lasso di tempo: Day 720
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 720

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Day 0 (Hour 0), 90, 570
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)
Lasso di tempo: Day 0 (Hour 0), 90, 570
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 dicembre 2008

Completamento primario (Effettivo)

16 agosto 2011

Completamento dello studio (Effettivo)

16 agosto 2011

Date di iscrizione allo studio

Primo inviato

23 luglio 2008

Primo inviato che soddisfa i criteri di controllo qualità

24 luglio 2008

Primo Inserito (Stima)

25 luglio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 novembre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 ottobre 2022

Ultimo verificato

1 ottobre 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A9951002
  • 2008-000986-42 (Numero EudraCT)
  • MD IN AD PATIENT (Altro identificatore: Alias Study Number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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