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

Phase 1

• Conditions: Cognitive impairment due to Alzheimer's Disease; MedDRA version: 20.0 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-005040-28-PT
• Lead Sponsor: nilfarma - União Internacional de Lab. Farmacêuticos, Lda.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-14
• Study Completion: 2017-10-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 386

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 month prior to screening and no change is foressen for the duartion 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 177
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 177

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 AB immunization and tau therapies. Previous participation in studies with non-presciption medications, vitamins or other nutitional formulations is allowed.
- Clinically significant uncompensated hearing loss in the judgment of the investigator. Use of hearing aids is allowed.

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 donepezil and placebo in patients with cognitive impairment due to Alzheimer's Disease;Secondary Objective: Not apppicable;<br> Primary end point(s): 1: Cognition as measured by change from baseline in Neuropsychological Test Battery (NTB) total score<br> ;<br> Timepoint(s) of evaluation of this end point: 1: 12 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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> ;<br> Timepoint(s) of evaluation of this end point: 1: 12 weeks<br> <br> 2: 12 weeks<br> <br> 3: 12 weeks<br>