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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00722046




Registration number
NCT00722046
Ethics application status
Date submitted
23/07/2008
Date registered
25/07/2008

Titles & IDs
Public title
Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease
Scientific title
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.
Secondary ID [1] 0 0
2008-000986-42
Secondary ID [2] 0 0
A9951002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - PF-04360365 0.1 mg/kg
Treatment: Other - PF-04360365 0.5 mg/kg
Treatment: Other - PF-04360365 1 mg/kg
Treatment: Drugs - Placebo
Treatment: Other - PF-04360365 3 mg/kg
Treatment: Other - PF-04360365 8.5 mg/kg

Experimental: PF-04360365 0.1 mg/kg -

Experimental: PF-04360365 0.5 mg/kg -

Experimental: PF-04360365 1 mg/kg -

Placebo comparator: Placebo -

Experimental: PF-04360365 3 mg/kg -

Experimental: PF-04360365 8.5 mg/kg -


Treatment: Other: PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)

Treatment: Other: PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)

Treatment: Other: PF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)

Treatment: Drugs: Placebo
Placebo every 60 days (10 doses total)

Treatment: Other: PF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)

Treatment: Other: PF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days (10 doses total)
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
Primary outcome [2] 0 0
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
Timepoint [2] 0 0
Baseline up to Month 24
Primary outcome [3] 0 0
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
Timepoint [3] 0 0
Baseline up to Month 24
Primary outcome [4] 0 0
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
Timepoint [4] 0 0
0 Hour on Day 0
Primary outcome [5] 0 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
Timepoint [5] 0 0
0 Hour (pre-dose) on Day 1
Primary outcome [6] 0 0
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1
Timepoint [6] 0 0
2 Hours on Day 1
Primary outcome [7] 0 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60
Timepoint [7] 0 0
0 Hour (pre-dose) on Day 60
Primary outcome [8] 0 0
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60
Timepoint [8] 0 0
2 Hours on Day 60
Primary outcome [9] 0 0
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90
Timepoint [9] 0 0
Day 90
Primary outcome [10] 0 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120
Timepoint [10] 0 0
0 Hour (pre-dose) on Day 120
Primary outcome [11] 0 0
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120
Timepoint [11] 0 0
2 Hours on Day 120
Primary outcome [12] 0 0
Mean Plasma Concentration of PF-04360365 on Day 150
Timepoint [12] 0 0
Day 150
Primary outcome [13] 0 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180
Timepoint [13] 0 0
0 Hour (pre-dose) on Day 180
Primary outcome [14] 0 0
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180
Timepoint [14] 0 0
2 Hours on Day 180
Primary outcome [15] 0 0
Mean Plasma Concentration of PF-04360365 on Day 210
Timepoint [15] 0 0
Day 210
Primary outcome [16] 0 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240
Timepoint [16] 0 0
0 Hour (pre-dose) on Day 240
Primary outcome [17] 0 0
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240
Timepoint [17] 0 0
2 Hours on Day 240
Primary outcome [18] 0 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300
Timepoint [18] 0 0
0 Hour (pre-dose) on Day 300
Primary outcome [19] 0 0
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300
Timepoint [19] 0 0
2 Hours on Day 300
Primary outcome [20] 0 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360
Timepoint [20] 0 0
0 Hour (pre-dose) on Day 360
Primary outcome [21] 0 0
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360
Timepoint [21] 0 0
2 Hours on Day 360
Primary outcome [22] 0 0
Mean Plasma Concentration of PF-04360365 on Day 390
Timepoint [22] 0 0
Day 390
Primary outcome [23] 0 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420
Timepoint [23] 0 0
0 Hour (pre-dose) on Day 420
Primary outcome [24] 0 0
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420
Timepoint [24] 0 0
2 Hours on Day 420
Primary outcome [25] 0 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480
Timepoint [25] 0 0
0 Hour (pre-dose) on Day 480
Primary outcome [26] 0 0
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480
Timepoint [26] 0 0
2 Hours on Day 480
Primary outcome [27] 0 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540
Timepoint [27] 0 0
0 Hour (pre-dose) on Day 540
Primary outcome [28] 0 0
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540
Timepoint [28] 0 0
2 Hours on Day 540
Primary outcome [29] 0 0
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570
Timepoint [29] 0 0
Day 570
Primary outcome [30] 0 0
Mean Plasma Concentration of PF-04360365 on Day 660
Timepoint [30] 0 0
Day 660
Primary outcome [31] 0 0
Mean Plasma Concentration of PF-04360365 on Day 720
Timepoint [31] 0 0
Day 720
Secondary outcome [1] 0 0
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19
Timepoint [2] 0 0
Baseline and Month 19
Secondary outcome [3] 0 0
Disability Assessment for Dementia (DAD) Score at Baseline
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19
Timepoint [4] 0 0
Baseline and Month 19
Secondary outcome [5] 0 0
Mean Plasma Concentration of Amyloid Beta 1-x (Aß1-x)
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Mean Plasma Concentration of Amyloid Beta 1-40 (Aß1-40)
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Mean Plasma Concentration of Amyloid Beta 1-42 (Aß1-42)
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aß1-x)
Timepoint [8] 0 0
Day 0 (Hour 0), 90, 570
Secondary outcome [9] 0 0
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aß1-40)
Timepoint [9] 0 0
Day 0 (Hour 0), 90, 570
Secondary outcome [10] 0 0
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aß1-42)
Timepoint [10] 0 0
Day 0 (Hour 0), 90, 570
Secondary outcome [11] 0 0
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
Timepoint [11] 0 0
Day 0 (Hour 0), 90, 570
Secondary outcome [12] 0 0
Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
Timepoint [12] 0 0
Baseline up to Month 24
Secondary outcome [13] 0 0
Number of Participants With Serum Anti-Drug Anti Body (ADA)
Timepoint [13] 0 0
Day 1 up to Month 24

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/08/2011
Sample size
Target
Accrual to date
Final
198
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital and Health Service - Woodville South
Recruitment hospital [3] 0 0
Heidelberg Repatriation Hospital, Austin Health - Heidelberg West
Recruitment hospital [4] 0 0
The McCusker Foundation for Alzheimer's Disease Research - Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg West
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Rhode Island
Country [7] 0 0
Belgium
State/province [7] 0 0
Antwerpen
Country [8] 0 0
Belgium
State/province [8] 0 0
Edegem
Country [9] 0 0
Belgium
State/province [9] 0 0
Jette
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Gyeonggi
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Chesire
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Wiltshire
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Manchester
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00722046