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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00722046
Ethics application status
Date submitted
23/07/2008
Date registered
25/07/2008
Date last updated
5/05/2016

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
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
Other interventions - PF-04360365 0.1 mg/kg
Other interventions - PF-04360365 0.5 mg/kg
Other interventions - PF-04360365 1 mg/kg
Treatment: Drugs - Placebo
Other interventions - PF-04360365 3 mg/kg
Other interventions - 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 -


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

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

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

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

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

Other interventions: PF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days (10 doses total)

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety/tolerability of PF-04360365 in subjects with mild to moderate Alzheimer's disease dosed for 18 months. (adverse events, physical/neurologic exams, vital signs, 12-lead ECG, clinical labs, brain MRI, cognitive assessments)
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Pharmacokinetics of PF-04360365 following administration of multiple doses in subjects with mild to moderate Alzheimer's disease. (plasma and cerebrospinal fluid (as available) PF-04360365 concentrations)
Timepoint [2] 0 0
24 months
Secondary outcome [1] 0 0
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog); Disability Assessment for Dementia (DAD); plasma/CSF Abeta; CSF tau and phosphotau; CSF protein, RBCs, WBCs and glucose; Immunogenicity (anti-drug antibodies)
Timepoint [1] 0 0
24 months

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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Woodville South
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Heidelberg West
Recruitment hospital [4] 0 0
Pfizer Investigational Site - 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-do
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Manchester
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Wiltshire
Country [18] 0 0
United Kingdom
State/province [18] 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/show/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
Other publications