Alzheimer's DiseasePhase 2NCT00722046

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

A Phase 2 study testing PF-04360365 0.1 mg/kg, PF-04360365 0.5 mg/kg and PF-04360365 1 mg/kg in people with Alzheimer's Disease, run by Pfizer at 42 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Alzheimer's Disease
What is being tested?: PF-04360365 0.1 mg/kg, PF-04360365 0.5 mg/kg and PF-04360365 1 mg/kg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 198 participants
Where: 42 sitesin 6 countries
Study dates: 5 Dec 2008to 16 Aug 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

42 sites in 6 countries.

Country

City, postcode or hospital

42 sites in 6 countries

United States15 sites

Memory Enhancement Center of America, Inc
Eatontown, New Jersey, 07724
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, 60007
Neuroscience Consultants, LLC
Miami, Florida, 33176
Central Jersey Radiology
Oakhurst, New Jersey, 07755
Stark Pharmacy
Overland Park, Kansas, 66209
Vince and Associates Clinical Research
Overland Park, Kansas, 66211
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
Pivotal Research Center
Peoria, Arizona, 85381
Sun Radiology- for MRI
Peoria, Arizona, 85381
Dedicated Phase 1
Phoenix, Arizona, 85013
Butler Hospital
Providence, Rhode Island, 02906
Miami Research Associates
South Miami, Florida, 33143
MRA Clinical Research
South Miami, Florida, 33143
Sleep Florida, LLC
South Miami, Florida, 33143

Other trials in United States

Canada7 sites

Parkwood Hospital, Geriatric Medicine
London, Ontario, N6C 5J1
Recherche Clinique de Neurologie
Montreal, Quebec, H1T 2M4
Kawartha Regional Memory Clinic
Peterborough, Ontario, K9H 2P4
Diex Recherche Inc.
Sherbrooke, Quebec, J1H 1Z1
Toronto Memory Program
Toronto, Ontario, M3B 2S7
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University of British Columbia Hospital, Division of Neurology
Vancouver, British Columbia, V6T 2B5

Other trials in Canada

South Korea6 sites

Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Hanyang University Hospital
Seoul, 133-792
Samsung Medical Center
Seoul, 135-710
Korea University Anam Hospital
Seoul, 136-705
Asan Medical Center
Seoul, 138-736
Konkuk University Medical Center
Seoul, 143-914

Other trials in South Korea

United Kingdom6 sites

The Pharmacy Department
Cheadle, Chesire, SK8 2PX
MAC UK Neuroscience Ltd
Manchester, M50 2GY
Wellcome Trust Clinical Research Facility
Southampton, SO16 6YD
Memory Assessment and Research Centre
Southampton, SO30 3JB
The Shalbourne Suite
Swindon, Wiltshire, SN3 6BB
Kingshill Research Centre
Swindon, Wiltshire, SN3 6BW

Other trials in United Kingdom

Australia4 sites

Royal Adelaide Hospital
Adelaide, South Australia, 5000
Heidelberg Repatriation Hospital, Austin Health
Heidelberg West, Victoria, 3084
The McCusker Foundation for Alzheimer's Disease Research
Nedlands, Western Australia, 6009
The Queen Elizabeth Hospital and Health Service
Woodville South, South Australia, 5011

Other trials in Australia

Belgium4 sites

ZNA Middelheim / Neurology
Antwerp, 2020
UZ Antwerpen, Department of Neurology
Edegem, 2650
UZ Brussel / Geriatrie
Jette, 1090
U.Z. Gasthuisberg / Neurologie
Leuven, 3000

Other trials in Belgium

About this study

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.

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.

Conditions: Alzheimer's Disease
Being tested: PF-04360365 0.1 mg/kg, PF-04360365 0.5 mg/kg, PF-04360365 1 mg/kg, Placebo, PF-04360365 3 mg/kg
Keywords: Alzheimer's disease, antibody, amyloid
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-04360365 0.1 mg/kgBiological
0.1 mg/kg every 60 days (10 doses total)
PF-04360365 0.5 mg/kgBiological
0.5 mg/kg every 60 days (10 doses total)
PF-04360365 1 mg/kgBiological
1 mg/kg every 60 days (10 doses total)
PlaceboDrug
Placebo every 60 days (10 doses total)
PF-04360365 3 mg/kgBiological
3 mg/kg every 60 days (10 doses total)
PF-04360365 8.5 mg/kgBiological
8.5 mg/kg every 60 days (10 doses total)

Study groups in NCT00722046
Study group	Role	What they receive
PF-04360365 0.1 mg/kg	Experimental	Not described Receives: Biological: PF-04360365 0.1 mg/kg
PF-04360365 0.5 mg/kg	Experimental	Not described Receives: Biological: PF-04360365 0.5 mg/kg
PF-04360365 1 mg/kg	Experimental	Not described Receives: Biological: PF-04360365 1 mg/kg
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
PF-04360365 3 mg/kg	Experimental	Not described Receives: Biological: PF-04360365 3 mg/kg
PF-04360365 8.5 mg/kg	Experimental	Not described Receives: Biological: PF-04360365 8.5 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study medication and up to 6 months after last dose that were absent before treatment or worsened relative to pre-treatment state.
Measured: Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral/meningeal enhancement, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyperintensities) were assessed from structural MRI. Participants with brain abnormality other than those listed above, assessed using MRI scan, were reported under other abnormality. Baseline was defined as the last assessment prior to the first study drug infusion.
Measured: Baseline up to Month 24
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI. Baseline was defined as the last assessment prior to the first study drug infusion.
Measured: Baseline up to Month 24
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 0 Hour on Day 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 0 Hour (pre-dose) on Day 1
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 2 Hours on Day 1
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 0 Hour (pre-dose) on Day 60
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 2 Hours on Day 60
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: Day 90
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 0 Hour (pre-dose) on Day 120
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 2 Hours on Day 120
Mean Plasma Concentration of PF-04360365 on Day 150
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: Day 150
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 0 Hour (pre-dose) on Day 180
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 2 Hours on Day 180
Mean Plasma Concentration of PF-04360365 on Day 210
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: Day 210
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 0 Hour (pre-dose) on Day 240
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 2 Hours on Day 240
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 0 Hour (pre-dose) on Day 300
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 2 Hours on Day 300
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 0 Hour (pre-dose) on Day 360
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 2 Hours on Day 360
Mean Plasma Concentration of PF-04360365 on Day 390
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: Day 390
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 0 Hour (pre-dose) on Day 420
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 2 Hours on Day 420
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 0 Hour (pre-dose) on Day 480
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 2 Hours on Day 480
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 0 Hour (pre-dose) on Day 540
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: 2 Hours on Day 540
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: Day 570
Mean Plasma Concentration of PF-04360365 on Day 660
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: Day 660
Mean Plasma Concentration of PF-04360365 on Day 720
Only participants received PF-04360365 were analyzed for this outcome measure.
Measured: Day 720

Secondary outcomes (13)

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Measured: Baseline
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Measured: Baseline and Month 19
Disability Assessment for Dementia (DAD) Score at Baseline
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Measured: Baseline
Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Measured: Baseline and Month 19
Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)
Measured: 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
Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)
Measured: 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
Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)
Results are not reported for PF-04360365 0.1, 0.5, 1.0 mg/kg, Placebo (Part A and B) arms because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
Measured: 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
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)
Measured: Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)
Measured: Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)
Measured: Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
Measured: Day 0 (Hour 0), 90, 570
Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
Abnormality was defined as concentration either less than lower limit of normal (LLN) or more than upper limit of normal (ULN). Baseline was defined as the last assessment prior to the first study drug infusion
Measured: Baseline up to Month 24
Number of Participants With Serum Anti-Drug Anti Body (ADA)
Serum samples were analyzed for the presence or absence of anti-PF-04360365 antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA). Only participants receiving PF-04360365 were analyzed for this outcome measure.
Measured: Day 1 up to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 200816 Aug 2011

First posted25 Jul 2008 (estimated)
Study start5 Dec 2008
Primary completion16 Aug 2011
Study completion16 Aug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 198 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00722046
Sponsor's protocol ID: A9951002
Other IDs: 2008-000986-42, MD IN AD PATIENT, 2008
Status last verified: Oct 2022
First submitted: 23 Jul 2008
Last updated: 7 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00722046
Acronym / sponsor ID: A9951002
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease, antibody, amyloid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 198 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 5 Dec 2008 (actual)
Primary completion: 16 Aug 2011 (actual)
Study completion: 16 Aug 2011 (actual)
First posted: 25 Jul 2008 (estimated)
Results: Posted 7 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
PF-04360365 0.1 mg/kg	Experimental	Biological: PF-04360365 0.1 mg/kg
PF-04360365 0.5 mg/kg	Experimental	Biological: PF-04360365 0.5 mg/kg
PF-04360365 1 mg/kg	Experimental	Biological: PF-04360365 1 mg/kg
Placebo	Placebo comparator	Drug: Placebo
PF-04360365 3 mg/kg	Experimental	Biological: PF-04360365 3 mg/kg
PF-04360365 8.5 mg/kg	Experimental	Biological: PF-04360365 8.5 mg/kg

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Males or females of non childbearing potential, age > or = 50
Diagnosis of probable Alzheimer's disease, consistent with criterial from both:
Mini-mental status exam score of 16-26 inclusive
Rosen-Modified Hachinski Ischemia Score of < or = 4

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-04360365 0.1 mg/kg0.1 mg/kg every 60 days (10 doses total)	Biological	PF-04360365 0.1 mg/kg
PF-04360365 0.5 mg/kg0.5 mg/kg every 60 days (10 doses total)	Biological	PF-04360365 0.5 mg/kg
PF-04360365 1 mg/kg1 mg/kg every 60 days (10 doses total)	Biological	PF-04360365 1 mg/kg
PlaceboPlacebo every 60 days (10 doses total)	Drug	Placebo
PF-04360365 3 mg/kg3 mg/kg every 60 days (10 doses total)	Biological	PF-04360365 3 mg/kg
PF-04360365 8.5 mg/kg8.5 mg/kg every 60 days (10 doses total)	Biological	PF-04360365 8.5 mg/kg

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study medication and up to 6 months after last dose that were absent before treatment or worsened relative to pre-treatment state.
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
Time frame: Baseline up to Month 24
Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral/meningeal enhancement, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyperintensities) were assessed from structural MRI. Participants with brain abnormality other than those listed above, assessed using MRI scan, were reported under other abnormality. Baseline was defined as the last assessment prior to the first study drug infusion.
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
Time frame: Baseline up to Month 24
Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI. Baseline was defined as the last assessment prior to the first study drug infusion.
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
Time frame: 0 Hour on Day 0
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
Time frame: 0 Hour (pre-dose) on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1
Time frame: 2 Hours on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60
Time frame: 0 Hour (pre-dose) on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60
Time frame: 2 Hours on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90
Time frame: Day 90
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120
Time frame: 0 Hour (pre-dose) on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120
Time frame: 2 Hours on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 on Day 150
Time frame: Day 150
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180
Time frame: 0 Hour (pre-dose) on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180
Time frame: 2 Hours on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 on Day 210
Time frame: Day 210
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240
Time frame: 0 Hour (pre-dose) on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240
Time frame: 2 Hours on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300
Time frame: 0 Hour (pre-dose) on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300
Time frame: 2 Hours on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360
Time frame: 0 Hour (pre-dose) on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360
Time frame: 2 Hours on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 on Day 390
Time frame: Day 390
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420
Time frame: 0 Hour (pre-dose) on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420
Time frame: 2 Hours on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480
Time frame: 0 Hour (pre-dose) on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480
Time frame: 2 Hours on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540
Time frame: 0 Hour (pre-dose) on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540
Time frame: 2 Hours on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570
Time frame: Day 570
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 on Day 660
Time frame: Day 660
Only participants received PF-04360365 were analyzed for this outcome measure.
Mean Plasma Concentration of PF-04360365 on Day 720
Time frame: Day 720
Only participants received PF-04360365 were analyzed for this outcome measure.

13 secondary outcomes

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
Time frame: Baseline
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19
Time frame: Baseline and Month 19
Disability Assessment for Dementia (DAD) Score at Baseline
Time frame: Baseline
Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19
Time frame: Baseline and Month 19
Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)
Time frame: 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
Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)
Time frame: 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
Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)
Time frame: 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
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)
Time frame: Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)
Time frame: Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)
Time frame: Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
Time frame: Day 0 (Hour 0), 90, 570
Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
Time frame: Baseline up to Month 24
Number of Participants With Serum Anti-Drug Anti Body (ADA)
Time frame: Day 1 up to Month 24

Results and safety

Results posted to the registry on 7 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-04360365 0.1 mg/kg (Part A)	26	21
PF-04360365 0.5 mg/kg (Part A)	26	20
PF-04360365 1.0 mg/kg (Part A)	25	18
Placebo (Part A)	26	18
PF-04360365 3.0 mg/kg (Part B)	32	23
PF-04360365 8.5 mg/kg (Part B)	31	20
Placebo (Part B)	32	26

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame: Day 1 up to 6 months after last dose of study medication, assessed up to Month 24. Count of participants. Unit: Participants

Measure	PF-04360365 0.1 mg/kg (Part A) n = 25	PF-04360365 0.5 mg/kg (Part A) n = 25	PF-04360365 1.0 mg/kg (Part A) n = 25	Placebo (Part A) n = 24	PF-04360365 3.0 mg/kg (Part B) n = 32	PF-04360365 8.5 mg/kg (Part B) n = 31	Placebo (Part B) n = 32
AEs	24	24	24	24	27	28	32
SAEs	7	8	7	3	7	10	3

Population analysed: Safety analysis set included all participants who received an infusion of study medication (including partial infusions).

Primary outcome: Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities

Time frame: Baseline up to Month 24. Count of participants. Unit: Participants

Measure	PF-04360365 0.1 mg/kg (Part A) n = 25	PF-04360365 0.5 mg/kg (Part A) n = 25	PF-04360365 1.0 mg/kg (Part A) n = 25	Placebo (Part A) n = 24	PF-04360365 3.0 mg/kg (Part B) n = 31	PF-04360365 8.5 mg/kg (Part B) n = 28	Placebo (Part B) n = 32
Cerebral Edema	0	1	0	0	0	0	0
Cerebral/Meningeal Enhancement	0	1	0	0	0	0	0
Micro Hemorrhage	4	7	2	6	3	6	6
Subdural Hematoma	0	1	0	0	0	0	0
Cortical Infarcts	1	0	2	0	0	1	0
Subcortical Grey Matter Infarcts	0	0	0	0	1	1	0
White Matter Infarcts	0	1	0	0	0	0	2
White Matter Hyper Intensities	0	3	2	2	4	0	2

Population analysed: Safety analysis set included all participants who received an infusion of study medication (including partial infusions). Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Primary outcome: Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)

Time frame: Baseline up to Month 24. Count of participants. Unit: Participants

Measure	PF-04360365 0.1 mg/kg (Part A) n = 25	PF-04360365 0.5 mg/kg (Part A) n = 25	PF-04360365 1.0 mg/kg (Part A) n = 25	Placebo (Part A) n = 24	PF-04360365 3.0 mg/kg (Part B) n = 31	PF-04360365 8.5 mg/kg (Part B) n = 28	Placebo (Part B) n = 32
Value	3	1	2	1	1	2	3

Primary outcome: Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0

Time frame: 0 Hour on Day 0. Mean (Standard Deviation). Unit: Nanogram per milliliter

Measure	PF-04360365 0.1 mg/kg (Part A) n = 3	PF-04360365 0.5 mg/kg (Part A) n = 8	PF-04360365 1.0 mg/kg (Part A) n = 4	PF-04360365 3.0 mg/kg (Part B) n = 13	PF-04360365 8.5 mg/kg (Part B) n = 11
Value	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)

Population analysed: Pharmacokinetic (PK) analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-04360365 0.1 mg/kg (Part A)	7 of 25 (28%)	24 of 25 (96%)	Not reported
PF-04360365 0.5 mg/kg (Part A)	8 of 25 (32%)	24 of 25 (96%)	Not reported
PF-04360365 1.0 mg/kg (Part A)	7 of 25 (28%)	23 of 25 (92%)	Not reported
Placebo (Part A)	3 of 24 (12.5%)	24 of 24 (100%)	Not reported
PF-04360365 3.0 mg/kg (Part B)	7 of 32 (21.9%)	26 of 32 (81.3%)	Not reported
PF-04360365 8.5 mg/kg (Part B)	10 of 31 (32.3%)	28 of 31 (90.3%)	Not reported
Placebo (Part B)	3 of 32 (9.4%)	32 of 32 (100%)	Not reported

Limitations and caveats (from the sponsor): Data for CSF protein, RBCs, WBCs, and glucose was recorded as number of participants with laboratory test abnormalities and not as change from baseline values as planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

42 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-04360365 0.1 mg/kg, PF-04360365 0.5 mg/kg and PF-04360365 1 mg/kg in people with Alzheimer's Disease, run by Pfizer at 42 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Canada, South Korea, United Kingdom, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: Day 1 up to 6 months after last dose of study medication, assessed up to Month 24). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00722046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.