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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00455000




Registration number
NCT00455000
Ethics application status
Date submitted
29/03/2007
Date registered
2/04/2007
Date last updated
14/10/2009

Titles & IDs
Public title
A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease
Scientific title
A Phase I, Randomized, Placebo Controlled, Double Blind Dose Escalation Study Of The Safety, Tolerability, Pharmacokinetics,Pharmacodynamics, And Immunogenicity Of A Single Intravenous Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease
Secondary ID [1] 0 0
A9951001
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
Treatment: Drugs - Placebo

Experimental: Active treatment - 5 possible active doses

Placebo Comparator: Placebo -


Other interventions: PF-04360365
Monoclonal antibody

Treatment: Drugs: Placebo
Placebo

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
To examine the safety, tolerability, and pharmacokinetics of a single dose of PF-04360365 in subjects with mild to moderate AD for one year following dosing.
Timepoint [1] 0 0
366 days
Secondary outcome [1] 0 0
To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.
Timepoint [1] 0 0
366 days

Eligibility
Key inclusion criteria
- Male or Females of non-childbearing potential, age 50-85

- Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1)
National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's
Disease and Related Disorders Association (NINCDS-ADRDA); and 2)Diagnostic and
Statistical Manual of Mental Disorders (DSM IV)

- Mini-mental status exam score of 16-26 inclusive

- Rosen-Modified Hachinski Ischemia Score < or = 4
Minimum age
50 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis or history of other dementia 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 1
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)
VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Heidelberg West
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Fremantle
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 0 0
6160 - Fremantle
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
Sweden
State/province [3] 0 0
Stockholm
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and
well tolerated in Adults with Mild to Moderate Alzheimer's disease.
Trial website
https://clinicaltrials.gov/show/NCT00455000
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