An 18-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of donepezil HCl (E2020) in patients with CADASIL who have cognitive impairment.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

5)Head MRI: Evidence of disease consistent with CADASIL, and no evidence of another disease, which might account for cognitive impairment or dementia (as judged by the Investigator/physician at the site). Must be obtained within 6 months of the Screening visit. If no such head MRI had been previously obtained, a head MRI will be obtained as part of Screening after all other inclusion and exclusion criteria (except clinical laboratory determinations) are satisfied. Patients in whom an MRI is contraindicated can have a CT instead, however, MRI is the preferred modality.
9)Patients with vitamin B12 deficiency who are on a stable dose of medication for at least 12 weeks prior to Baseline and who have normal or elevated serum B12 levels at Screening will be eligible. Patients who might otherwise have been eligible can be re-screened when they meet this criterion. This stable dose of vitamin B12 must be maintained throughout the study. Patients with high serum levels of vitamin B12 or folate are eligible.
10)Patients with hypothyroidism or hyperthyroidism who are on a stable dose of medication for at least 12 weeks prior to Baseline are eligible. If Screening laboratory testing of thyroid function (TSH and free T4) abnormalities are found, patients will not be considered ineligible if they are on a stable dose of medication for at least 12 weeks prior to Baseline or they are considered euthyroid by their primary care physician and are therefore not eligible for medication therapy. Patients who might otherwise have been eligible can be re-screened when they meet this criterion. This stable dose must be maintained throughout the study.
11)Patients must have a reliable study partner who has regular contact with the patient (e.g, an average of 4 or more contacts per week), can observe for possible adverse events, and can accompany the patient to visits as described in Section 10.5.
12)Patients with a history of hypertension, cardiac disease, diabetes, or peripheral vascular disease, may be enrolled in the study provided that the following standards are met. Hypertension must be medication controlled (sitting SBP < 175, sitting DBP < 100 mm Hg) (per Administrative Change 01) and cardiac disease (e.g. angina pectoris, congestive heart failure, right bundle branch block, or arrhythmias) is stable on appropriate medication for 12 weeks prior to Screening. Peripheral vascular disease must have been stable for 12 weeks prior to Screening. No elective surgical procedures should be planned during the course of the study (e.g. hernia repair and bunion removal). Patient with diabetes must be stable as demonstrated by an HbA1c of = 8.0% or a random serum glucose value of = 170 mg/dL. Patients with abnormal glucose values at Screening, who are not considered diabetic by their personal physicians, will be considered eligible. Patients with HbA1c values in the diabetic range must be stable before study entry.
13)All patients with CADASIL are at risk for stroke / TIA and may be enrolled in the study provided that no new strokes have been diagnosed or identified to have occurred within the three months prior to Screening. Patients who might otherwise be eligible can be screened 12 weeks after the stroke. Patients with TIAs are eligible without a waiting period. Patients who are already enrolled will continue in the study as assessed by the Investigator/physician.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1

Exclusion Criteria

11)Use of any unapproved prior or concomitant medications as defined in Sections 8.4 and Appendix 2 (This list is not exhaustive. If there are questions, please ask the Medical Monitor.) (per Administrative Change 01) For allowed medications that act on cognition, anti-depressants for example, the dosage and the condition treated (e.g., depression) must be stable for 12 weeks prior to enrollment. If a medication is used to treat a condition that does not affect the patient's cognition, in the opinion of the investigator, then the wash-out period is 6 weeks. The wash-out for oxybutinin, an anti-cholinergic agent, is 4 weeks for 5mg/day and 8 weeks for higher dosages. Similar agents will likewise have dose-dependent wash-outs. Please ask the medical monitor.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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