Phase 2
N=36
A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00945672 ↗Enrolled (actual)
36
Serious AEs
11.1%
Results posted
Apr 2024
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) — 9; 5; 10; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-04360365 10 mg/kg (Biological); PF-04360365 7.5 mg/kg (Biological); placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
9; 5; 10; 5; 2; 1 | — |
| PRIMARY Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities |
1; 0; 1; 1; 2; 0 | — |
| PRIMARY Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI) |
0; 0; 0; 0 | — |
| PRIMARY Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M |
2.781; 2.835; 2.480; 2.647; 2.492; 2.626 | — |
| PRIMARY Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0 |
0.00; 0.00 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1 |
0.00; 0.00 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 1 |
191080.73; 190826.33 | — |
| PRIMARY Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 10: Cohort M |
167.25; 77466.25 | — |
| PRIMARY Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 20: Cohort M |
192.50; 68219.25 | — |
| PRIMARY Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 30: Cohort M |
185.33; 46321.00 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 30: Cohort M |
196752.82 | — |
| PRIMARY Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 40: Cohort Q |
121.73; 34794.50 | — |
| PRIMARY Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 50: Cohort Q |
107.03; 40038.50 | — |
| PRIMARY Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 60: Cohort Q |
84.50; 22917.00 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 60: Cohort M |
62261.92 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 60: Cohort M |
199861.90 | — |
| PRIMARY Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 90 |
61.15; 16094.08; 68110.83 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 90 |
218031.73; 212299.30 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120: Cohort M |
73285.25 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 120: Cohort M |
227156.80 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 150: Cohort M |
76083.50 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 150: Cohort M |
222737.91 | — |
| PRIMARY Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 180 |
89.20; 324.82; 23708.42; 76593.58 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 180 |
226842.91; 210905.00 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 210: Cohort M |
77315.33 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 210: Cohort M |
223667.00 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240: Cohort M |
82563.83 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 240: Cohort M |
223715.91 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 270 |
22140.00; 69838.25 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 270 |
219643.86; 218116.27 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300: Cohort M |
71822.18 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 300: Cohort M |
227333.20 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 330: Cohort M |
71668.67 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 330: Cohort M |
216841.22 | — |
| PRIMARY Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 360 |
68.71; 240.19; 20347.00; 70238.33 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 360 |
222927.73; 213278.09 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 720 Hours Post-dose on Day 360: Cohort Q |
59095.22 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 390: Cohort M |
74846.08 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 540: Cohort Q |
6245.83 | — |
| PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540: Cohort M |
5987.08 | — |
| PRIMARY 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 |
31150.00; 28533.33; 30497.50; 28500.00; 15794.17; 13296.67 | — |
| PRIMARY 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 |
22.32; -21.21; 9.24; 1.43; -0.46; -3.78 | — |
| PRIMARY 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 |
-2.38; -5.95; 4.23; -8.75; 8.14; -24.57 | — |
| PRIMARY 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 |
0.80; -0.79; 43.33; -17.07; 14.15; -13.98 | — |
| PRIMARY 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 |
16.78; 5.05; 26.77; 160.62; 17.30; -7.40 | — |
| PRIMARY 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 |
12.35; -1.60; -17.98; -6.67; 2.32; -3.36 | — |
| PRIMARY 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 |
9.62; 0.04; 27.85; -5.61; 9.52; -12.08 | — |
| PRIMARY 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 |
-0.51; -15.57; 27.67; -23.23; -15.62; -38.65 | — |
| PRIMARY 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 |
-37.94; -44.49; 13.91; -0.57; -60.93; -60.42 | — |
| PRIMARY 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 |
-16.70; -30.01; -27.69; -42.16; 98.33; 35.60 | — |
| SECONDARY Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18 |
18.6; 23.5; 18.2; 20.1; 0.5; 1.9 | 0.9779 |
| SECONDARY Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Month 6, 13 and 18 |
90.2; 85.6; 75.4; 87.3; -2.1; -3.4 | 0.8205 |
| SECONDARY Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Month 13 |
21.8; 20.3; 20.7; 21.7; -1.5; -3.3 | 0.4855 |
| SECONDARY Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x) |
128.92; 136.00; 190.67; 167.17; 454.50; 191.17 | — |
| SECONDARY Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40) |
219.44; 136.60; 166.20; 157.20; 618.00; 163.67 | — |
| SECONDARY Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42) |
4.62; 85.23; 41.05; 11.82; 5.76; 73.23 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
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.
Data sourced from ClinicalTrials.gov (NCT00945672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.