Trial Outcomes & Findings for Progression Delaying Effect of Escitalopram in Alzheimer's Disease (NCT NCT00702780)

NCT ID: NCT00702780

Last Updated: 2014-06-13

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

74 participants

Primary outcome timeframe

52 weeks

Results posted on

2014-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	Escitalopram escitalopram 20mg qd	Placebo placebo 20mg qd
Overall Study STARTED	37	37
Overall Study COMPLETED	28	29
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Progression Delaying Effect of Escitalopram in Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escitalopram n=28 Participants escitalopram 20mg qd	Placebo n=29 Participants placebo 20mg qd	Total n=57 Participants Total of all reporting groups
Age, Continuous	74.33 years STANDARD_DEVIATION 7.12 • n=5 Participants	74.82 years STANDARD_DEVIATION 9.19 • n=7 Participants	74.58 years STANDARD_DEVIATION 8.17 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.

Outcome measures

Outcome measures
Measure	Escitalopram n=28 Participants escitalopram 20mg qd	Placebo n=29 Participants placebo 20mg qd
% Change of Hippocampus Volume	-7.63 percentage of change Standard Deviation 7.32	-7.28 percentage of change Standard Deviation 5.76

PRIMARY outcome

Timeframe: 52 weeks

Population: The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.

Outcome measures

Outcome measures
Measure	Escitalopram n=28 Participants escitalopram 20mg qd	Placebo n=29 Participants placebo 20mg qd
% Change of Whole Brain Volume	-3.27 percentage of change Standard Deviation 2.69	-2.30 percentage of change Standard Deviation 3.08

Adverse Events

Escitalopram

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Escitalopram n=37 participants at risk Escitalopram 20mg qd	Placebo n=37 participants at risk Placebo 20mg qd
Hepatobiliary disorders Jaundice	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Social circumstances Death by traffic accident	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Vascular disorders Cerebral hemorrhage	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Gastrointestinal disorders Vomiting	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.

Other adverse events

Additional Information

Young Min Choe

Seoul National University Hospital

Phone: 82-2-2072-1730

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Escitalopram n=37 participants at risk Escitalopram 20mg qd	Placebo n=37 participants at risk Placebo 20mg qd
Nervous system disorders dizziness	10.8% 4/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Gastrointestinal disorders vomiting	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Gastrointestinal disorders anorexia	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Gastrointestinal disorders abdominal pain	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Gastrointestinal disorders diarrhea	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Gastrointestinal disorders constipation	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Respiratory, thoracic and mediastinal disorders cough	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Respiratory, thoracic and mediastinal disorders bronchitis	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
General disorders somnolence	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Nervous system disorders tremor	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Injury, poisoning and procedural complications fall	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Psychiatric disorders violent behavior	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Renal and urinary disorders urinary incontinence	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Endocrine disorders hypoglycemia	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	0.00% 0/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) cancer	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.	2.7% 1/37 • Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.