BI 425809 in patients with cognitive impairment due to Alzheimer's Disease.
- Conditions
- Cognitive impairment due to Alzheimer's DiseasePatients with diagnosis of mild-to moderate Alzheimer’s dementia according to the recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease.MedDRA version: 20.0Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-005438-24-FI
- Lead Sponsor
- Boehringer Ingelheim Finland Ky
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 851
- Patients with signs of dementia of Alzheimer Type
- Male and female patients with an age of at least 55 years
- MMSE 15-26
- All patients must sign and date an Informed Consent Form personally
- Concomitant use of AChEIs is allowed but not required. 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 who are not currently taking AChEIs but have taken them in the past are also eligible if AChEIs were stopped at least 3 months prior to screening.
- 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 293
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 292
- Dementia secondary to disorders other than Alzheimer's Disease Dementia. Lewy body dementia or vascular or multi-infarct dementia as
primary diagnosis is excluded.
performed at screening.
- Any central nervous system disease other than AD which according to the investigator
may be associated with worsening of cognition. Patients with epileptic seizure in last 2
years should be excluded.
- A disease or condition which in the opinion of the investigator are likely to interfere
with trial testing procedures or put the patient at risk when participating in this trial.
- Any documented active or suspected malignancy or history of malignancy with need of
concomitant treatment that interfere with the investigational product.
- Patients with life expectancy of less than 2 years are also excluded.
- Any other clinical condition that, in the opinion of the investigator, would jeopardize
patient safety while participating in this clinical trial.
- Severe renal impairment defined as a GFR < 30 mL/min/1.73 m2 in the screening central lab report.
- Haemoglobin less than 120 g/L (12g/dL) in men or 115g/L (11.5g/dL) in women in the
screening lab report.
- Clinically significant uncompensated hearing loss in the judgment of the investigator.
Use of hearing aids is allowed.
- Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt,
aborted attempt, or preparatory acts or behaviour).
- Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with
plan and intent).
- Known history of HIV infection.
- Significant history of drug dependence or abuse (including alcohol, as defined in
Diagnostic and Statistical Manual of Mental Disorders [DSM-V] or in the opinion of the
investigator) within the last two years.
- Previous participation in investigational drug studies of dementia of Alzheimer’s Type
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 other
nutritional formulations or non-pharmacological treatments is allowed.
- Treatment with restricted medication.
- Planned elective surgery requiring general anaesthesia, or hospitalisation for more than
1 day (requiring an overnight stay) during the study period.
- For females: Women who are of child bearing potential. Women not of childbearing
potential are defined as: Women who are postmenopausal (12 months with no menses
without an alternative medical cause) or who are permanently sterilized (e.g.
hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
For males: Men who are able to father a child, unwilling to be abstinent or to use an
adequate form of effective contraception for the duration of study participation and for
at least 28 days after treatment has ended.
- Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess safety, tolerability and efficacy of different doses of BI 425809 compared to placebo in treatment of cognitive impairment due to Alzheimer¿s Disease;Secondary Objective: Not applicable;Primary end point(s): 1. The change from baseline in ADAS-Cog11 (Alzheimer’s Disease Assessment Scale-<br>Cognitive subscale 11 item) total score after 12 weeks of treatment<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 the ADCS-ADL (Alzheimer’s Disease Cooperative Study/Activities of Daily Living) score after 12weeks of treatment<br>2. CIBIC+ (Clinician's Interview-Based Impression of Change) score after 12 weeks of treatment;Timepoint(s) of evaluation of this end point: 1: 12 weeks<br><br>2: 12 weeks<br>