Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease, escitalopram, MRI
Brief summary
This study aimed to test whether escitalopram would slow the brain atrophy in patients with mild to moderate AD over the 52-week period.
Detailed description
* Study institutions: Four university hospitals in Korea * Design: Multi-center, randomized, placebo-controlled, double-blind clinical trial * Subjects: 74 probable Alzheimer's disease patients who have been taking donepezil at stable dose within 2 months (Escitalopram 37 : Placebo 37)
Interventions
DRUGescitalopram
5 mg/day for 2 weeks, 10 mg/day for 2 weeks and 20 mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period)
DRUGplacebo
5mg/day for 2 weeks, 10mg/day for 2 weeks and 20mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period)
Sponsors
H. Lundbeck A/S
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age:40\ 90 years * Education:not illiterate * Clinical Dementia Rating (CDR):0.5\ 2 * Modified Hachinski Ischemic Score (Rosen et al., 1979):less than 4 * Dementia according to DSM-IV criteria * Probable Alzheimer's disease according to NINCDS-ADRDA criteria * Current ongoing donepezil medication at stable doses (5 \ 10 mg/day) for at least 2 months
Exclusion criteria
* Evidence of delirium, confusion or altered consciousness * Evidence of Parkinson's disease, stroke, brain tumor and normal pressure hydrocephalus * Evidence of infectious or inflammatory brain disease * Evidence of serious cerebrovascular diseases * Current major depressive disorder or other major psychiatric illnesses * Evidence of serious or unstable medical illnesses which can significantly change cognitive state * History of alcohol or other substance dependence * Any antidepressant medications within the previous 4 weeks * Absence of a reliable and cooperative collateral informant * Any conditions which prohibit MRI scan, such as presence of pacemaker or cerebrovascular clip, and claustrophobia * Evidence of focal brain lesions on MRI including lacunes and white matter hyperintensity lesions of grade 2 or more by Fazeka scale
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % Change of Hippocampus Volume | 52 weeks |
| % Change of Whole Brain Volume | 52 weeks |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Escitalopram escitalopram 20mg qd | 28 |
| Placebo placebo 20mg qd | 29 |
| Total | 57 |
Baseline characteristics
| Characteristic | Escitalopram | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 74.33 years STANDARD_DEVIATION 7.12 | 74.82 years STANDARD_DEVIATION 9.19 | 74.58 years STANDARD_DEVIATION 8.17 |
| Sex: Female, Male Female | 15 Participants | 21 Participants | 36 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 37 | 7 / 37 |
| serious Total, serious adverse events | 2 / 37 | 3 / 37 |
Outcome results
Primary
% Change of Hippocampus Volume
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | % Change of Hippocampus Volume | -7.63 percentage of change | Standard Deviation 7.32 |
| Placebo | % Change of Hippocampus Volume | -7.28 percentage of change | Standard Deviation 5.76 |
Primary
% Change of Whole Brain Volume
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | % Change of Whole Brain Volume | -3.27 percentage of change | Standard Deviation 2.69 |
| Placebo | % Change of Whole Brain Volume | -2.30 percentage of change | Standard Deviation 3.08 |