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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
Date last updated
7/11/2022

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
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.
Trial website
https://clinicaltrials.gov/study/NCT00722046
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00722046