BI 409306 in patients with cognitive impairment due to Alzheimer's Disease

Phase 1

Conditions: Cognitive impairment due to Alzheimer's Disease
MedDRA version: 18.0Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2013-005040-28-IT

Lead Sponsor: Boehringer Ingelheim Italia S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

- Patients with early signs of dementia of Alzheimer Type
- Male and female patients with an age of at least 55 years
- Previous use of AD medications (AChEIs, memantine) is allowed up 3
month prior to screening. Patients who are currently taking AChEIs are
eligible as long as they have been using a stable dose for at least 3
months prior to screening and no change is foreseen for the duration of
the study. This dose must be consistent with the product label in the
concerned country. Patients currently taking memantine are excluded.
- 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.
- Patients must have a reliable study partner (per investigator
judgement, for instance a family member, partner etc., guardian or, if
applicable, a legal representative)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168

Exclusion Criteria

- Cognitive impairment or dementia with any etiology other than AD
- Substantial concomitant cerebrovascular disease (defined by a history of a stroke / intracranial haemorrhagia) temporally related to the onset
of worsening of cognitive impairment per investigator judgement
- Medical history or diagnosis of any of symptomatic and
unstable/uncontrolled conditions per investigator judgement
- Any other psychiatric disorders such as schizophrenia, or mental
retardation
- Previous participation in investigational drug studies of mild cognitive
impairment/DAT within three months prior to screening. Having
received active treatment in any other study targeting disease
modification of AD like Aß immunization and tau therapies. Previous
participation in studies with non-prescription medications, vitamins or
other nutritional formulations is allowed.
- Clinically significant uncompensated hearing loss in the judgment of
the investigator. Use of hearing aids is allowed.
E.5

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess efficacy, safety and tolerability of BI 409306 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease;Secondary Objective: Not apppicable;Primary end point(s): 1: Cognition as measured by change from baseline in Neuropsychological Test Battery (NTB) total score<br>;Timepoint(s) of evaluation of this end point: 1: 12 weeks<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1: Change from baseline in ADCS-ADL total score<br><br>2: Change from baseline in ADAS-cog11<br><br>3: Change from baseline in CDR-SB total score<br>;Timepoint(s) of evaluation of this end point: 1: 12 weeks<br><br>2: 12 weeks<br><br>3: 12 weeks<br>