Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment
Brief summary
This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).
Interventions
5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
DRUGplacebo
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 90 Years
Inclusion criteria
1. Age Range: Adult subjects (45 to 90 years of age inclusive) 2. Sex distribution: Men and women. Women of child-bearing potential (\<1 year post menopausal) must be practicing effective contraception and have negative serum B-HCG at Screening. \[Women who are breast-feeding are excluded.\] 3. Subjects must have completed the one year, double-blind core trial (E2020-A001-412). 4. A completed Diagnostic Worksheet at the end of the double-blind core trial (E2020-A001-412) indicating no conversion to Alzheimer's Disease or dementia. 5. Health: Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane). 6. The subject must be expected to complete the entire study. 7. Subjects must be sufficiently fluent in English. 8. Subjects must have an informant who has daily contact with the subject (e.g., an average of 10 or more hours per week), can observe for possible adverse events and will accompany the subject to all visits. 9. Clinical laboratory values must be within normal limits, or if abnormal, judged clinically insignificant by the investigator (not likely to cause cognitive impairment or medical instability).
Exclusion criteria
1. Subjects who have not completed or have terminated early from the one year, double-blind core trial (E2020-A001-412). 2. Any subject without a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412). 3. Any subject with a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412) indicating conversion to Alzheimer's or other dementia. 4. Subjects with uncontrolled hypertension (sitting systolic \>= 160mmHg and/or diastolic \>=95mmHg) as assessed by the investigator, regardless of whether or not the subject is taking anti-hypertensive medications. 5. Subjects with a history of malignant neoplasms treated within five years prior to study entry (other than basal or squamous cell carcinoma of the skin); current evidence of malignant neoplasm; or recurrent or matastatic disease. 6. Subjects who have suffered a severe infection or a major surgical procedure within three months prior to baseline. 7. Subjects who may not be able to comply with the protocol. 8. Subjects with known hypersensitivity to piperidine derivatives or acetylcholinesterase(AChE)inhibitors. 9. Subjects with diabetes mellitis not controlled by diet and/or medication with a random serum glucose value of \>170mg/dl. 10. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study. 11. Subjects who do not have a reliable informant (e.g., the informant has contact with the subject less than 10 hours per week).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | Baseline, Week 6, Week 12 and Week 28. | Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Donepezil 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day. | 68 |
| Placebo | 77 |
| Total | 145 |
Baseline characteristics
| Characteristic | Donepezil | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 71.7 years STANDARD_DEVIATION 8.46 | 73.4 years STANDARD_DEVIATION 8.73 | 72.6 years STANDARD_DEVIATION 8.62 |
| Region of Enrollment United States | 68 participants | 77 participants | 145 participants |
| Sex: Female, Male Female | 30 Participants | 36 Participants | 66 Participants |
| Sex: Female, Male Male | 38 Participants | 41 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 68 | 20 / 77 |
| serious Total, serious adverse events | 3 / 68 | 2 / 77 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events
Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)
Time frame: Baseline, Week 6, Week 12 and Week 28.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | Number of Participants With Treatment-Emergent Adverse Events | Any Serious TEAE | 3 Participants |
| Donepezil | Number of Participants With Treatment-Emergent Adverse Events | Any Severe TEAE | 2 Participants |
| Donepezil | Number of Participants With Treatment-Emergent Adverse Events | Any possibly/probably drug-related TEAE | 16 Participants |
| Donepezil | Number of Participants With Treatment-Emergent Adverse Events | Any TEAE causing discontinuation of study drug. | 7 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events | Any TEAE causing discontinuation of study drug. | 17 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events | Any Serious TEAE | 2 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events | Any possibly/probably drug-related TEAE | 32 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events | Any Severe TEAE | 3 Participants |