Phase 4
N=97
The Effectiveness And Safety Of Donepezil Hydrochloride (E2020) In Subjects With Mild To Severe Alzheimer's Disease Residing In An Assisted Living Facility
Mild to Severe Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00571064 ↗Enrolled (actual)
97
Serious AEs
12.4%
Results posted
Mar 2018
Primary outcome: Primary: Mini Mental State Examination (MMSE) Total Scores by Visit — 18.7; 20.8; 20.5; 20.5 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Donepezil HCl (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mini Mental State Examination (MMSE) Total Scores by Visit |
18.7; 20.8; 20.5; 20.5 | — |
| PRIMARY Change From Baseline in MMSE Total Score by Visit |
18.7; 1.8; 1.9; 1.8 | <0.0001 sig |
| SECONDARY Caregiver Activity Survey (CAS) Total Time by Visit |
8.9; 9.0; 9.0; 9.3 | — |
| SECONDARY Change From Baseline in CAS Total Time by Visit |
8.9; 0.3; 0.3; 0.3 | 0.6593 |
| SECONDARY Neuropsychiatric Inventory (NPI-8) Total Score by Visit |
5.7; 3.9; 3.9 | — |
| SECONDARY Change From Baseline in NPI-8 Total Score by Visit |
5.7; -1.8; -1.8 | 0.0431 sig |
| SECONDARY Alzheimer Disease-related Quality of Life (ADRQL) Total Score by Visit |
48.7; 47.6; 47.6 | — |
| SECONDARY Change From Baseline in ADRQL Total Score by Visit |
48.7; -1.1; -1.1 | 0.1285 |
| SECONDARY Disability Assessment in Dementia (DAD) Total Score by Visit |
58.3; 58.4; 57.2; 57.2 | — |
| SECONDARY Change From Baseline in DAD Total Score by Visit |
58.3; -1.1; -1.1; -1.1 | 0.2327 |
Summary
This is a study to determine the effectiveness and safety of donepezil hydrochloride (E2020) used to treat residents of assisted living facilities diagnosed with mild, moderate, or severe stage Alzheimer's disease.
Eligibility Criteria
Inclusion Criteria
- Age range: Subjects > 50 years of age.
- Sex distribution: both men and women. Women must be two (2) years post-menopausal or surgically sterile. Women of child bearing potential ( 3 months.
- Subjects with recent (< 2 years) hematologic/ oncologic disorders, not including mild anemia or basal or squamous cell carcinoma of the skin. Subjects with current evidence of malignant neoplasm or recurrent or metastatic disease will be excluded.
- Evidence of clinically significant, active gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
- Subject with a current DSM-lV diagnosis of Major Depressive Disorder (MDD) or any current primary psychiatric diagnosis other than Alzheimer's disease (as per DSM-lV).
- Subjects with dementia complicated by other organic disease (DSM 290.30 or 290.11) are excluded; depression or delusions are common in Alzheimer's disease, and subjects with severe symptoms so pronounced that they warrant an alternative, concurrent diagnosis, are excluded.
- Subjects with a known or suspected history of alcoholism or drug abuse (within the past 10 years).
- Subjects with treated hypothyroidism that have not been on a stable dose of medication for 3 months prior to screening and who do not have normal serum Free T3, Free T4 and TSH at screening.
- Subjects with treated vitamin B-12 deficiency who have not been on a stable dose of medication for at least 3 months prior to the study screening visit and who do not have normal serum B-12 levels at screening.
- Any subject taking a prohibited medication will be excluded.
- Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study.
Data sourced from ClinicalTrials.gov (NCT00571064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.