Alzheimer's Research & Therapy

Table 3 Treatment-emergent adverse events occurring in ≥2 patients in any treatment group––First In Human

From: First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer’s disease

Adverse event	AAB-003
	0.5 mg/kg (N = 6)	1 mg/kg (N = 6)	2 mg/kg (N = 16)	4 mg/kg (N = 17)	8 mg/kg (N = 24)	Placebo (N = 19)
	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Anxiety	0	0	2 (12.5)	0	0	2 (10.5)
ARIA-E	0	0	0	0	2 (8.3)	0
ARIA-H	0	0	1 (6.3)	0	2 (8.3)*	0
Back pain	0	0	2 (12.5)	0	1 (4.2)	0
Decreased appetite	0	2 (33.3)	3 (18.8)	2 (11.8)	0	0
Dizziness	0	0	2 (12.5)	2 (11.8)	1 (4.2)	2 (10.5)
Fall	0	0	2 (12.5)	1 (5.9)	0	1 (5.3)
Gait disturbance	0	0	1 (6.3)	2 (11.8)	0	1 (5.3)
Headache	1 (16.7)	1 (16.7)	0	2 (11.8)	1 (4.2)	1 (5.3)
Nasopharyngitis	1 (16.7)	0	1 (6.3)	0	2 (8.3)	1 (5.3)
Nausea	1 (16.7)	0	1 (6.3)	0	2 (8.3)	1 (5.3)
Sinusitis	0	1 (16.7)	0	0	2 (8.3)	0
Urinary tract infection	1 (16.7)	0	1 (6.3)	0	2 (8.3)	0
Weight increased	0	0	0	0	2 (8.3)	0
Vomiting	0	0	0	1 (5.9)	2 (8.3)	1 (5.3)

*One case was not reported as an adverse event (ARIA-H incidence based on central magnetic resonance imaging reporting was 12.5 %). ARIA-E Amyloid-related imaging abnormalities with edema/effusions, ARIA-H Amyloid-related imaging abnormalities indicative of microhemorrhages and hemosiderosis

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