A multi-centre, double-blind, parallel-group, randomized controlled study to investigate the efficacy, safety and tolerability of orally administred BI 409306 during a 12-week treatment period compared to placebo in patients with Alzheimer's disease.

Phase 2

Completed

Conditions: prodromal Alzheimer Disease/Alzheimer Disease
10029305

Registration Number: NL-OMON42045

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

Written Informed Consent, 55 years or older, minimal 50 kg.
Patients with diagnosis of prodromal AD in accordance with the recommendation of the International Working Group (IWG), Dubois et al. 2007
Symptoms noticed by the patients
Cognitive testing confirming prodromal symptoms
Biomarker evidence of AD pathology
No evidence of other forms of dementia
No other concomitant illness or medication which could confound or prohibit completion in the trial by the patient

Exclusion Criteria

Other forms of dementia, or a psychiatrical disorder or severe depression
Substantial concomitant cerebrovascular disease, Medical history of cancer, Significant ischemic heart disease, Significant gastrointestinal disorders, Uncontrolled endocrine disease, Significant pulmonary disease predisposing to hypoxia, Immunological disorders, Unstable/uncontrolled haematological disease, Any other systemic or multiple organ dysfunctions, Severe renal impairment, Any suicidal actions in the past 2 years, Previous participation in investigational drug studies of mild cognitive impairment within three months prior to screening, HIV or syphilis infection confirmed by a central lab test, intake of restricted medications as per protocol, pre-menopausal women not able or willing to take appropriate birth control, breast feeding women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in cognition as measured by change from baseline in Neuropsychological<br /><br>Test Battery (NTB - total score) after 12-week treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change from baseline in ADCS-MCI-ADL total score after 12-week treatment<br /><br>Change from baseline in CDR-SB total score after 12-week treatment<br /><br>Change from baseline in ADAS-cog11 (Alzheimer's Disease Assessment<br /><br>Scale-cognitive subscale) total score after 12-week treatment</p><br>