BI 425809 in patients with cognitive impairment due to Alzheimer's Disease.

Phase 1

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

• Registration Number: EUCTR2015-005438-24-AT
• Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-27
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 950

Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified