Phase 2 N=198 Randomized Triple-blind Treatment

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

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT00722046 ↗

Enrolled (actual)

198

Serious AEs

23.2%

Results posted

Nov 2022

Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) — 24; 24; 24; 24 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PF-04360365 0.1 mg/kg (Biological); PF-04360365 0.5 mg/kg (Biological); PF-04360365 1 mg/kg (Biological); Placebo (Drug); PF-04360365 3 mg/kg (Biological); PF-04360365 8.5 mg/kg (Biological)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Aug 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	24; 24; 24; 24; 27; 28	—
PRIMARY Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities	0; 1; 0; 0; 0; 0	—
PRIMARY Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)	3; 1; 2; 1; 1; 2	—
PRIMARY Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0	0.00; 0.00; 0.00; 0.00; 0.00	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1	0.00; 0.00; 14.25; 0.00; 38.10	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1	1731.36; 10051.85; 21972.09; 65832.36; 187953.19	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60	33.96; 792.80; 1747.04; 6715.34; 30517.76	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60	2018.13; 11372.46; 23100.33; 81464.62; 209962.13	—
PRIMARY Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90	0.00; 0.00; 6.36; 43.44; 157.40; 286.20	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120	106.08; 1259.68; 2573.64; 8781.20; 31916.04	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120	2083.14; 12229.60; 25263.43; 69437.52; 191019.54	—
PRIMARY Mean Plasma Concentration of PF-04360365 on Day 150	344.17; 2512.36; 4673.32; 17636.10; 53918.22	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180	114.71; 1344.00; 2819.68; 9885.71; 30306.81	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180	1959.05; 12096.22; 24574.57; 72597.58; 194768.61	—
PRIMARY Mean Plasma Concentration of PF-04360365 on Day 210	245.33; 2419.25; 4935.00; 17973.43; 55881.07	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240	170.64; 1423.83; 2782.17; 11221.22; 31093.81	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240	1660.76; 10501.00; 22340.46; 80142.40; 216585.87	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300	176.25; 1690.41; 2958.13; 11935.88; 31766.30	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300	1919.42; 10774.35; 22273.26; 76511.29; 207292.95	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360	247.52; 1377.95; 3161.00; 10643.58; 31485.52	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360	2019.23; 11047.68; 22833.43; 71309.58; 203124.84	—
PRIMARY Mean Plasma Concentration of PF-04360365 on Day 390	411.00; 2344.76; 4902.36; 18721.04; 54956.65	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420	204.62; 1433.52; 3102.24; 9711.42; 30782.57	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420	1919.50; 11513.89; 23519.67; 69975.00; 196647.81	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480	162.52; 1480.95; 3125.25; 10585.67; 26612.45	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480	1936.67; 11293.26; 22930.21; 67981.00; 169955.72	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540	177.30; 1297.26; 2718.38; 10372.65; 32303.09	—
PRIMARY Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540	1981.20; 11291.40; 20793.73; 70660.14; 178273.50	—
PRIMARY Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570	0.00; 0.00; 6.30; 56.77; 115.36; 360.05	—
PRIMARY Mean Plasma Concentration of PF-04360365 on Day 660	10.33; 480.78; 1212.22; 4196.50; 7576.29	—
PRIMARY Mean Plasma Concentration of PF-04360365 on Day 720	0.00; 198.70; 590.56; 1583.22; 2795.30	—
SECONDARY Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline	20.0; 20.4; 20.8; 20.0; 19.4; 24.5	—
SECONDARY Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19	8.36; 9.00; 9.25; 6.98; 9.58; 8.71	0.6504
SECONDARY Disability Assessment for Dementia (DAD) Score at Baseline	79.6; 83.4; 78.1; 78.0; 83.5; 77.1	—
SECONDARY Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19	-20.09; -16.20; -15.18; -16.02; -22.53; -18.12	0.4688
SECONDARY Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)	294.12; 229.68; 355.80; 273.21; 607.50; 337.87	—
SECONDARY Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)	185.52; 145.92; 162.04; 180.54; 318.09; 192.03	—
SECONDARY Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)	NA; NA; NA; NA; 13.43; 19.14	—
SECONDARY Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)	27400.00; 30187.50; 32150.00; 18425.00; 31553.85; 25536.36	—
SECONDARY Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)	18100.00; 11907.50; 11700.00; 7947.50; 14672.31; 12301.82	—
SECONDARY Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)	983.00; 800.13; 851.75; 694.00; 959.54; 817.36	—
SECONDARY Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)	188.90; 223.79; 190.43; 96.13; 219.09; 167.40	—
SECONDARY Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration	1; 3; 1; 3; 4; 4	—
SECONDARY Number of Participants With Serum Anti-Drug Anti Body (ADA)	0; 0; 0; 0; 0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00722046). 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.