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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00722046
Collaborator
(none)
198
Enrollment
38
Locations
6
Arms
32
Duration (Months)
5.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: PF-04360365 0.1 mg/kg
  • Biological: PF-04360365 0.5 mg/kg
  • Biological: PF-04360365 1 mg/kg
  • Drug: Placebo
  • Biological: PF-04360365 3 mg/kg
  • Biological: PF-04360365 8.5 mg/kg
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
198 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official 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
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: PF-04360365 0.1 mg/kg

Biological: PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)
Experimental: PF-04360365 0.5 mg/kg

Biological: PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)
Experimental: PF-04360365 1 mg/kg

Biological: PF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)
Placebo Comparator: Placebo

Drug: Placebo
Placebo every 60 days (10 doses total)
Experimental: PF-04360365 3 mg/kg

Biological: PF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)
Experimental: PF-04360365 8.5 mg/kg

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

Outcome Measures

Primary Outcome Measures

  1. 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) [24 months]

  2. 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) [24 months]

Secondary Outcome Measures

  1. 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) [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Peoria Arizona United States 85381
2 Pfizer Investigational Site Phoenix Arizona United States 85013
3 Pfizer Investigational Site Miami Florida United States 33176
4 Pfizer Investigational Site South Miami Florida United States 33143
5 Pfizer Investigational Site Elk Grove Village Illinois United States 60007
6 Pfizer Investigational Site Overland Park Kansas United States 66209
7 Pfizer Investigational Site Overland Park Kansas United States 66211
8 Pfizer Investigational Site Overland Park Kansas United States 66212
9 Pfizer Investigational Site Eatontown New Jersey United States 07724
10 Pfizer Investigational Site Oakhurst New Jersey United States 07755
11 Pfizer Investigational Site Providence Rhode Island United States 02906
12 Pfizer Investigational Site Adelaide South Australia Australia 5000
13 Pfizer Investigational Site Woodville South South Australia Australia 5011
14 Pfizer Investigational Site Heidelberg West Victoria Australia 3084
15 Pfizer Investigational Site Nedlands Western Australia Australia 6009
16 Pfizer Investigational Site Antwerpen Belgium 2020
17 Pfizer Investigational Site Edegem Belgium 2650
18 Pfizer Investigational Site Jette Belgium 1090
19 Pfizer Investigational Site Leuven Belgium 3000
20 Pfizer Investigational Site Vancouver British Columbia Canada V6T 2B5
21 Pfizer Investigational Site London Ontario Canada N6C 5J1
22 Pfizer Investigational Site Peterborough Ontario Canada K9H 2P4
23 Pfizer Investigational Site Toronto Ontario Canada M3B 2S7
24 Pfizer Investigational Site Toronto Ontario Canada M4N 3M5
25 Pfizer Investigational Site Montreal Quebec Canada H1T 2M4
26 Pfizer Investigational Site Sherbrooke Quebec Canada J1H 1Z1
27 Pfizer Investigational Site Sungnam-si Gyeonggi-do Korea, Republic of 463-707
28 Pfizer Investigational Site Seoul Korea, Republic of 133-792
29 Pfizer Investigational Site Seoul Korea, Republic of 135-710
30 Pfizer Investigational Site Seoul Korea, Republic of 136-705
31 Pfizer Investigational Site Seoul Korea, Republic of 138-736
32 Pfizer Investigational Site Seoul Korea, Republic of 143-914
33 Pfizer Investigational Site Trafford Park Manchester United Kingdom M32 0UT
34 Pfizer Investigational Site Swindon Wiltshire United Kingdom SN3 6BB
35 Pfizer Investigational Site Swindon Wiltshire United Kingdom SN3 6BW
36 Pfizer Investigational Site Manchester United Kingdom M32 0UT
37 Pfizer Investigational Site Southampton United Kingdom SO16 6YD
38 Pfizer Investigational Site Southampton United Kingdom SO30 3JB

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00722046
Other Study ID Numbers:
  • A9951002
First Posted:
Jul 25, 2008
Last Update Posted:
May 5, 2016
Last Verified:
Oct 1, 2012
Keywords provided by Pfizer
Alzheimer's disease
antibody
amyloid
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of May 5, 2016