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Alzheimer's DiseasePhase 2NCT00945672

A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease

A Phase 2 study testing PF-04360365 10 mg/kg and PF-04360365 7.5 mg/kg in people with Alzheimer's Disease, run by Pfizer at 4 sites in Sweden.

Completed

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

Official record
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Trial summary

The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients 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 10 mg/kg and PF-04360365 7.5 mg/kg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
4 sitesSweden
Study dates
6 Aug 2009to 1 Jun 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 criteria 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

4 sites in 1 country.

Sweden4 sites

  • Sahlgrenska Sjukhuset, CTC

    Gothenburg, 413 45

  • Malmo Sjukhus, Neuropsykiatriska Kliniken

    Malmö, 205 02

  • Sahlgrenska Universitetssjukhuset, Minnesmottagningen

    Mölndal, 431 41

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 141 86

Other trials in Sweden

About this study

Official title: A PHASE 2 DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS/ PHARMACODYNAMICS OF PF-04360365 IN MILD TO MODERATE ALZHEIMER'S DISEASE PATIENTS

The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.

Being tested
PF-04360365 10 mg/kg, PF-04360365 7.5 mg/kg, placebo
Keywords
Alzheimer's disease amyloid imaging antibody
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 10 mg/kgBiological

    10 mg/kg every 90 days (5 total doses)

  • PF-04360365 7.5 mg/kgBiological

    10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses)

  • placeboDrug

    placebo administered every 90 days or monthly to match experimental treatment arms.

Study groups in NCT00945672
Study groupRoleWhat they receive
PF-04360365 10 mg/kgExperimentalNot described
Receives: Biological: PF-04360365 10 mg/kg
PF-04360365 7.5 mg/kgExperimentalNot described
Receives: Biological: PF-04360365 7.5 mg/kg
placeboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

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

  1. 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 are events between first dose of study medication and up to 6 months after last dose (up to 18 months) that were absent before treatment or worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.

    Measured: Day 1 up to 6 months after last dose of study medication (up to 18 months)

  2. 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 edema, cerebral/meningeal enhancement, micro hemorrhage, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyper intensities) were assessed from structural magnetic resonance imaging (MRI). Participants with brain abnormality other than those listed above assessed using MRI scan were reported under 'other' category. Only those MRI findings in which at least 1 participant had event, were reported.

    Measured: Baseline up to Month 18

  3. 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.

    Measured: Baseline up to Month 18

  4. Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M

    Quantitative amyloid imaging was performed using PET technique using [11C] Pittsburgh Compound B (PIB) for following brain areas: frontal, temporal, parietal and occipital cortices, anterior and posterior cingular cortex, cerebellum, pons, and subcortical white matter. For target regions of interest, beta-amyloid plaque imaging radiotracer (PIB) retention data was expressed as standard uptake value ratio (SUVR) which was defined as a ratio of radioactivity uptake of the target region relative to the cerebellum reference region. This outcome measure was planned to be analyzed only for cohort M.

    Measured: Baseline, Month 13

  5. Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour on Day 0 (Day prior to dosing)

  6. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 1

  7. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 1

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 1

  8. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 10: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 216 hours post dose on Day 1 (samples taken on Day 10)

  9. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 20: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 456 hours post dose on Day 1 (samples taken on Day 20)

  10. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 30: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 30

  11. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 30: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 30

  12. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 40: Cohort Q

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 936 hours post dose on Day 1 (samples taken on Day 40)

  13. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 50: Cohort Q

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 1176 hours post dose on Day 1 (samples taken on Day 50)

  14. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 60: Cohort Q

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 1416 hours post-dose on Day 1 (samples taken on Day 60)

  15. Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 60: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 60

  16. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 60: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 60

  17. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 90

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 90

  18. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 90

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 90

  19. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 120

  20. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 120: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 120

  21. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 150: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 150

  22. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 150: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 150

  23. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 180

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 180

  24. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 180

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 180

  25. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 210: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 210

  26. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 210: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 210

  27. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 240

  28. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 240: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 240

  29. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 270

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 270

  30. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 270

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 270

  31. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 300

  32. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 300: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 300

  33. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 330: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 330

  34. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 330: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 330

  35. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 360

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 360

  36. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 360

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0.25 hours post-infusion start on Day 360

  37. Mean Plasma Concentration of PF-04360365 at 720 Hours Post-dose on Day 360: Cohort Q

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 720 hours post-dose on Day 360 (samples taken on Day 390)

  38. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 390: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 390

  39. Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 540: Cohort Q

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hours (pre-dose) on Day 540

  40. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540: Cohort M

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

    Measured: 0 hour (pre-dose) on Day 540

  41. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0

    A-beta is a peptide fragment of the amyloid precursor protein (found in the brain of participants suffering from of Alzheimer's disease (AD). In this outcome, CSF concentration of 3 variants of A-beta were reported: A-beta (1-X), A-beta (1-40) and A-beta (1-42).

    Measured: 0 hour on Day 0 (Day prior to dosing)

  42. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M

    Measured: 216 hours post-dose on Day 1

  43. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M

    Measured: 456 hours post-dose on Day 1

  44. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M

    Measured: 0 hour (pre-dose) on Day 30

  45. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q

    Measured: 936 hours post-dose on Day 1 (Samples taken on Day 40)

  46. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q

    Measured: 1176 hours post-dose on Day 1 (Samples taken on Day 50)

  47. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q

    Measured: 1416 hours post-dose on Day 1 (Samples taken on Day 60)

  48. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q

    Measured: 0 hour (pre-dose) on Day 90

  49. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180

    Measured: 0 hour (pre-dose) on Day 180

  50. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360

    Measured: 0 hour (pre-dose) on Day 360

Secondary outcomes (6)

  1. Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18

    ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprises 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). The total score was calculated as the sum of the scores for the 11 items. ADAS-cog total score ranges from 0 (no impairment) to 70 (maximum impairment). Higher total and individual item scores indicate greater cognitive impairment.

    Measured: Baseline, Month 3, 6, 9, 13, 18

  2. Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Month 6, 13 and 18

    DAD is a functional assessment based on interview with the caregiver of participants. It consists of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item scored as yes = 1, no = 0 and not applicable= N/A. A total score is obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A are not considered for the total score. DAD total score range from 0 (more dysfunction) to 100 (better function), with higher scores indicating better functioning.

    Measured: Baseline, Month 6, 13, 18

  3. Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Month 13

    Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total MMSE score ranged from 0 (worst cognitive state) to 30 (best cognitive state), where higher score indicates better cognitive state.

    Measured: Baseline, Month 13

  4. Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)

    Measured: Cohort M&Q: 0 hour(hr) & 0.25 hrs post dose (pd) on Day (D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936,1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D 60, 0 hr & 0.25 hrs pd on D 30,120,150,210,240,300,330

  5. Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)

    Measured: Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390,540; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330

  6. Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)

    Measured: Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330

Timeline

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

  1. First posted24 Jul 2009 (estimated)
  2. Study start6 Aug 2009
  3. Primary completion1 Jun 2011
  4. Study completion1 Jun 2011

Resources

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
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00945672
Sponsor's protocol ID
A9951007
Other IDs
2009-011172-30, PIB/PET IMAGING, 2009
Status last verified
Nov 2023
First submitted
22 Jul 2009
Last updated
19 Apr 2024
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-04360365 10 mg/kg and PF-04360365 7.5 mg/kg in people with Alzheimer's Disease, run by Pfizer at 4 sites in Sweden.

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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden. 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 19 Apr 2024). 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 (up to 18 months)). The study lists 50 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 NCT00945672.

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 19 Apr 2024.

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