A pilot study to evaluate the effect of CT1812 treatment on synaptic density and other biomarkers in Alzheimer’s disease

Table 2 Safety results from primary 24 week study

	Placebo (N = 7)	CT1812 100 mg (N = 8)	CT1812 300 mg (N = 8)	Total (N = 23)
Number (%) of Subjects with TEAE [Number of TEAEs]
TEAEs	5 (71%) [8]	8 (100%) [24]	5 (63%) [20]	18 (78%) [52]
Mild	3 (43%) [6]	6 (75%) [21]	4 (50%) [16]	13 (57%) [43]
Moderate	1 (14%) [1]	1 (12.5%) [1]	1 (13%) [4]	2 (9%) [6]
Severe	1 (14%) [1]	2 (25%) [2]	0 (0%)	3 (13%) [3]
Related TEAEs	3 (43%) [3]	3 (38%) [3]	4 (50%) [7]	10 (43%) [13]
TEAEs leading to treatment discontinuation	1 (14%) [1]	2 (25%) [2]	2 (25%) [2]	5 (22%) [5]
SAEs	1 (14%) [1]	2 (25%) [3]	0 (0%)	3 (13%) [4]
Related SAEs	0 (0%)	0 (0%)	0 (0%)	0 (0%) [0]
Number (%) of Subjects with Treatment-Related^a TEAE [Number of TEAEs]
Headache	1 (14%) [1]	1 (13%) [1]	3 (38%) [3]	5 (22%) [5]
Dizziness	0 (0%)	1 (13%) [1]	1 (13%) [2]	2 (9%) [3]
Liver function test increase	0 (0%)	0 (0%)	2 (25%) [2]	2 (9%) [2]
Vomiting	1 (14%) [1]	1 (13%) [1]	0 (0%)	2 (9%) [2]
Diarrhea	1 (14%) [1]	0 (0%)	0 (0%)	1 (4%) [1]
Total related TEAEs	3 (43%) [3]	3 (38%) [3]	4 (50%) [7]	10 (43%) [13]

Top: Number and percentage of subjects experiencing an event and the total number of events in brackets for the six-month primary study period are summarized. The denominator for percentage corresponds to the N in each column. N is the number of subjects in the Safety Analysis Set. Bottom: AEs were coded using MedDRA version 21.0. TEAEs are events that occurred or worsened on or after the first application of study drug. Subjects are only counted once for each system organ class (SOC) and once for each preferred term (PT). The severity shown is the greatest severity reported for a particular subject. TEAE Treatment-emergent adverse event, SAE Severe adverse event; ^aRelated = possibly, probably, or definitely related

ISSN: 1758-9193