A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).

This 52-week study consisted of 16-week randomized placebo-controlled (RCT, including 12-week Confirmatory Phase) and 36-week open-label extension phases. Of 142 DLB patients enrolled in the RCT phase (three arms: placebo, 5 mg, and 10 mg), 110 entered the extension phase. The placebo group of the RCT phase initiated active treatment at week 16, and the active groups maintained allocated treatment and dosages until week 24. After week 24, all patients received 10 mg. Dose reduction to 5 mg for safety concerns was allowed.

Inclusion Criteria

1. Patients diagnosed as probable dementia with Lewy bodies (DLB) according to the consensus diagnostic criteria for DLB
2. Patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution
3. Clinical Dementia Rating (CDR) score ≥ 0.5
4. Mini-Mental State Examination (MMSE) score of 10 to 26

Exclusion Criteria

1. Patients diagnosed with Parkinson's disease with dementia (PDD)
2. Patients who received anti-dementia drug therapy at the same institution
3. Patients who received anti-dementia drug therapy within 12 weeks before start of Screening
4. Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency
5. Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)
6. Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening