Phase 4
Completed N=145
A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment
Source: ClinicalTrials.gov NCT00934375 ↗Enrolled (actual)
145
Serious AEs
3.5%
Results posted
Jul 2009
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events — 3; 2; 2; 3 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events |
3; 2; 2; 3; 16; 32 | — |
Eligibility Criteria
Inclusion Criteria
- Age Range: Adult subjects (45 to 90 years of age inclusive)
- Sex distribution: Men and women. Women of child-bearing potential ( = 160mmHg and/or diastolic >=95mmHg) as assessed by the investigator, regardless of whether or not the subject is taking anti-hypertensive medications.
- 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.
- Subjects who have suffered a severe infection or a major surgical procedure within three months prior to baseline.
- Subjects who may not be able to comply with the protocol.
- Subjects with known hypersensitivity to piperidine derivatives or acetylcholinesterase(AChE)inhibitors.
- Subjects with diabetes mellitis not controlled by diet and/or medication with a random serum glucose value of >170mg/dl.
- Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
- Subjects who do not have a reliable informant (e.g., the informant has contact with the subject less than 10 hours per week).
Data sourced from ClinicalTrials.gov (NCT00934375). 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.