BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: Placebo; Drug: Donepezil; Drug: BI 409306

Study type: Interventional

Funder types: Industry

Identifiers

NCT02337907

2013-005040-28 (EudraCT Number)

1289.7

Details and patient eligibility

About

The study is designed to compare the effects of BI 409306 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease

Enrollment: 329 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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 Alzheimer's Disease (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)

Exclusion criteria

• Cognitive impairment or dementia with any etiology other than Alzheimer's Disease (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/Dementia of Alzheimer Type (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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329 participants in 6 patient groups, including a placebo group

Placebo comparator

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

BI 409306 dose 1

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: BI 409306

BI 409306 dose 2

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: BI 409306

BI 409306 dose 3

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: BI 409306

Active Comparator Donepezil

Active Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Donepezil

BI 409306 dose 4

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: BI 409306