The primary objective of this study is to assess efficacy and safety of BI 409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily compared to placebo over a 12-week treatment period in patients with the following criteria: mild…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cognition as measured by change from baseline in Neuropsychological Test
Battery (NTB) total z-score after 12-week treatment.
Secondary outcome
1. Change from baseline in ADCS total score after 12-week treatment
2. Change from baseline in ADL total score after 12-week treatment
3. Change from baseline in CDR-SB (Clinical Dementia Rating Scale Sum of
Boxes) total score after 12-week treatment
4. Change from baseline in ADAS-cog (Alzheimer*s Disease Assessment
Scale-cognitive subscale) total score after 12-week treatment
Background summary
Dementia of Alzheimer*s Type (DAT), a chronic progressive mental disorder
caused by Alzheimer*s Disease (AD), is the most common cause of dementia and
accounts for 50 to 70% of all cases. AD is mainly a disorder of the elderly.
The age-specific prevalence of AD almost doubles every 5 years after age 65. In
the early stage of the clinical disease manifestation cardinal symptoms are
characterized by an impairment of episodic memory and other cognitive domains,
like executive function, orientation and judgment. This is followed by a
progressive decline in the ability to perform activities of daily living and
the appearance of behavioral changes and/or psychiatric symptoms (mood
disturbances, hallucinations, personality changes). With progression of the
disease there is an increasing utilization of resources and medical care
finally leading to the need of full-time assisted living or nursing home care
before death. The median time from onset of symptoms to death is estimated to
be around 10 years.
Currently approved AD treatment is purely symptomatic. A symptomatic treatment
that proves to be more efficacious than the currently available compounds
(AchE-Is, memantine) in improving both existing cognition deficits and the
ability to better perform activities of daily living would provide an
additional choice to patients and doctors.
Study objective
The primary objective of this study is to assess efficacy and safety of BI
409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily
compared to placebo over a 12-week treatment period in patients with the
following criteria: mild dementia of Alzheimer*s type aged at least 55 years.
Study design
A multi-centre, double-blind, parallel-group, randomised active and placebo
controlled study in patients with cognitive impairment caused by Alzheimer's
Disease.
297 patients randomised.
After written informed consent, patients will start the 3 week screening
period. All patients that succesfully complete screening will start with a 2
week single blind placebo run in period. Thereafter a 12 week double blind
treatment period will start. At visit 3 randomization to one of 5 treatment
arms will occur: QD 10 mg, 25 mg of 50 mg BI 409306, or BID 25 mg BI 409306, or
placebo. Followed by a 4 week follow up period.
Intervention
Please see table 4.1.1. of the clinical trial protocol.
Study burden and risks
3 weeks screening period, 2 weeks placebo run-in period (v 1 en 2), 12 weeks
treatment period with 5 visits, 2 phone contacts, and 1 follow up visit.
physical examination, vital signs, questionnaires, routine laboratory tests,
vitamin B12 and foliumacid, bloodtest for syphilis and HIV, urine pregnancy
tests (if applicable), drug screen test, optional bloodsample for biomarkers,
liver function test (from safety lab blood sample), urine samples for standard
tests, ECG, MRI (if applicable).
Comeniusstraat 6
Alkmaar 1817 MS
NL
Comeniusstraat 6
Alkmaar 1817 MS
NL
Listed location countries
Age
Inclusion criteria
- Written informed consent
- Diagnosis of mild Alzheimer*s Dementia
- MMSE score of 18-26, ADAS-cog score > 12 and a global CDR score of 1 or greater at screening
- Male and female patients with an age of at least 55 years
- Patients must have a reliable study partner (per investigator judgement, for instance a family member, partner etc., guardian or, if applicable, a legal representative)
- 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.
- 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 months prior to screening and no change is foreseen for the duration of the study. Patients currently taking memantine are excluded
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 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.;For additional exclusion criteria see protocol section 3.3.3
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-005040-28-NL |
| ClinicalTrials.gov | NCT02337907 |
| CCMO | NL51433.056.14 |