Phase 4
Completed 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
Source: ClinicalTrials.gov NCT00571064 ↗
Enrolled (actual)
97
Serious AEs
12.4%
Results posted
Mar 2018
Primary outcomePrimary: Mini Mental State Examination (MMSE) Total Scores by Visit — 18.7; 20.8; 20.5; 20.5 Scores on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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. Informational only — not medical advice.