PoCC/dose-finding in Mild to Moderate AD

Phase 2

Completed

• Conditions: Alzheimer's Disease

• Registration Number: JPRN-jRCT2080223912
• Lead Sponsor: ippon Boehringer Ingelheim Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-25
• Study Completion: 2020-05-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 585

Inclusion Criteria

1. Patients with early signs of dementia of Alzheimer Type
2. Male and female patients with an age of at least 55 years
3. Patients must have at least 6 years of formal education and fluency in the test language as verbally confirmed by the patient and documented by the study investigator.
Further inclusion criteria apply

Exclusion Criteria

1. Cognitive impairment or dementia with any etiology other than Alzheimer's Dementia (AD)
2. Medical history or diagnosis of any of symptomatic and unstable/uncontrolled conditions per investigator judgement
3. Patients receiving prescribed drugs for treatment of dementia of Alzheimer Type (other than Acetylcholine Esterase Inhibitors) at screening or within 3 months prior to screening
Further exclusion criteria apply

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>exploratory<br>The change from baseline in ADAS-Cog11 (Alzheimer's Disease Assessment Scale-Cognitive subscale 11 item) total score

Secondary Outcome Measures

Name	Time	Method
efficacy<br>exploratory<br>Change from baseline in the ADCS-ADL (Alzheimer's Disease Cooperative Study/Activities of Daily Living) score<br>efficacy<br>exploratory<br>CIBIC+ (Clinician's Interview-Based Impression of Change) score