Phase 2
N=329
BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT02337907 ↗Enrolled (actual)
329
Serious AEs
4.9%
Results posted
Nov 2018
Primary outcome: Primary: Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment. — 0.13; 0.17; 0.16; 0.01 Z-score — p=0.7907
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); BI 409306 (Drug); Donepezil (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment. |
0.13; 0.17; 0.16; 0.01; 0.12; 0.15 | 0.7907 |
| PRIMARY Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment From Two Sister Trials, Present 1289.5 (NCT02240693) and 1289.7 (NCT02337907) |
0.20; 0.19; 0.19; 0.10; 0.17; 0.19 | 0.8694 |
| SECONDARY Change From Baseline in Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Total Score After 12-week Treatment |
0.10; -0.99; 0.35; -1.07; -0.58 | 0.5287 |
| SECONDARY Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Total Score After 12-week Treatment |
0.1; 0.3; 0.1; 0.2; 0.1 | 0.7551 |
| SECONDARY Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11) Total Score After 12-week Treatment |
1.14; 0.94; 1.11; 2.29; -0.18 | 0.1595 |
Summary
The study is designed to compare the effects of BI 409306 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02337907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.