parallel randomized trial

S002980

Design

Randomized: 32
Start year: 2016
Treatment: 32 weeks, follow-up 32 weeks
Countries: Italy (1 sites)
Sponsor: (not reported)
Eligibility: age 50 to 80; mild cognitive impairment (Petersen); MMSE 24 to 27; no diabetes; BMI above 22

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Standard care or no added treatment No treatment	lifestyle: not reported	15	14
A2	Exenatide extended release 2 mg subcutaneous once weekly Exenatide	lifestyle: not reported	17	17

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Standard care or no added treatment A1	Exenatide extended release 2 mg subcutaneous once weekly A2	Whole trial ALL
age	mean (years)	72	74
age	sd (years)	6	4
bmi: more than 30	n	4	2
bmi: more than 30	percent	27	12
bmi	mean (kg/m2)	27.6	27.0
bmi	sd (kg/m2)	3.3	3.6
egfr	mean (mL/min/1.73 m2)	81	83
egfr	sd (mL/min/1.73 m2)	12	11
female	n			16
hba1c	mean (mmol/mol)	37	35
hba1c	sd (mmol/mol)	3	4
sbp	mean (mmHg)	132	133
sbp	sd (mmHg)	14	19
waist	mean (cm)	98.5	96.1
waist	sd (cm)	11.5	6.9
weight	mean (kg)	75.8	70.5
weight	sd (kg)	11.4	10.5

10 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 14	not stated; other; R0011213:Results
	A2	events				0 / 17	not stated; other; R0011213:Results

Discontinuation due to adverse events (1 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				6 / 17	not stated; randomized; R0011213:Figure 1

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 14	not stated; other; R0011213:Table 3

Vomiting (1 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 14	not stated; other; R0011213:Table 3

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 14	not stated; other; R0011213:Table 3

Constipation (1 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 14	not stated; other; R0011213:Table 3

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				5 / 17	not stated; randomized; loss of appetite, weight loss, gastric discomfort; R0011213:Figure 1

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 14	not stated; other; R0011213:Results
	A2	events				0 / 17	not stated; other; R0011213:Results