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

Alzheimer Disease Clinical Trial

Official title:

A Multi-centre, Double-blind, Parallel-group, Randomised Controlled Study to Investigate Efficacy, Safety and Tolerability of Orally Administered BI 409306 During a 12-week Treatment Period Compared to Placebo in Patients With Cognitive Impairment Due to Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02337907
• Other study ID #: 1289.7
• Secondary ID: 2013-005040-28
• Status: Completed
• Phase: Phase 2
• Start date: January 21, 2015
• Est. completion date: October 10, 2017

Study information

• Verified date: October 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: October 10, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction

Intervention

Drug:
• Placebo
for blinding purposes
• Placebo

• BI 409306

• Donepezil

Locations

Country	Name	City	State
Austria	Private Practice for Psychiatry and Neurology	Wien
Belgium	Brussels-UNIV Brugmann -Horta	Brussel
Belgium	AZ Sint-Blasius	Dendermonde
Belgium	UNIV UZ Gent	Gent
Belgium	Mons - UNIV Ambroise Paré	Mons
Canada	University of Calgary	Calgary	Alberta
Canada	Dr. Alexander McIntyre Inc.	Penticton	British Columbia
Canada	Institut universitaire de geriatrie Sherbrooke	Quebec
Canada	Pasqua Hospital	Regina	Saskatchewan
France	HOP Pellegrin	Bordeaux
France	HOP Bocage	Dijon
France	HOP Timone	Marseille
France	HOP Gui de Chauliac	Montpellier
France	HOP Nord Laënnec	Nantes
France	HOP La Pitié Salpêtrière	Paris
France	HOP Jean Bernard, Géria, Poitiers	Poitiers
Germany	emovis GmbH	Berlin
Germany	Praxis Dr. med. Volker Schumann	Berlin
Germany	St. Josef- und St. Elisabeth-Hospital gGmbH	Bochum
Germany	Neuro Centrum Science GmbH	Erbach
Germany	AFL Arzneimittelforschung Leipzig GmbH	Leipzig
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Zentralinstitut für seelische Gesundheit	Mannheim
Germany	Universitätsklinikum Ulm	Ulm
Germany	Neurologie und Psychiatrie / Psychotherapie	Westerstede
Italy	P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna	Bologna
Italy	Azienda Ospedaliera Careggi	Firenze
Italy	Azienda Ospedaliera di Parma	Parma
Netherlands	Jeroen Bosch Ziekenhuis-Hertogenbosch	's-HERTOGENBOSCH
Netherlands	Brain Research Center	Amsterdam
Poland	Podlassian Center of Psychogeriatry, Bialystok	Bialystok
Poland	Mental Health Center Biomed	Kielce
Poland	Inst. of Rural Health, Spec. Outp. Clin. & Rural Occup. Dis.	Lublin
Poland	Non-Public Outpatient Clinic Neuromed M. i M. Nastaj	Lublin
Poland	Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners	Poznan
Poland	Medical Center Senior	Sopot
Poland	EUROMEDIS Sp. z o.o., Szczecin	Szczecin
Poland	Reg. Specialist Hospital Wroclaw, Research & Develop. Center	Wroclaw
Portugal	Hospital Fernando Fonseca, EPE	Amadora
Portugal	Hospital de Braga-Escala Braga	Braga
Portugal	CHUC - Centro Hospitalar e Universitário de Coimbra, EPE	Coimbra
Portugal	Hospital Senhora Oliveira Guimarães,EPE	Guimarães
Portugal	CHLO, EPE - Hospital Egas Moniz	Lisboa
Portugal	Hospital Beatriz Ângelo	Loures
Portugal	ULSM, EPE - Hospital Pedro Hispano	Matosinhos
Portugal	Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião	Santa Maria da Feira
United Kingdom	Royal United Hospital	Bath
United Kingdom	Ninewells Hospital & Medical School	Dundee, Scotland
United Kingdom	West Devon (Tavistock) CMHT & Memory Clinic (EDI)	Ivybridge
United Kingdom	Re-Cognition Health	Plymouth
United States	The Memory Clinic	Bennington	Vermont
United States	ANI Neurology, PLLC, dba Alzheimer's Memory Center	Charlotte	North Carolina
United States	Memory Enhancement Center of America, Inc.	Eatontown	New Jersey
United States	Indiana University	Indianapolis	Indiana
United States	Bioclinica Research	Orlando	Florida
United States	Psychiatry And Alzheimer's Care of Rochester, PLLC	Rochester	New York
United States	California Neuroscience Research	Sherman Oaks	California
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Tulsa Clinical Research, LLC	Tulsa	Oklahoma
United States	Premiere Research Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Poland,  Portugal,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment.	Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. Least Squares Mean is actually an adjusted mean change from baseline.	Baseline and 12 weeks
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)	Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. The number of low test scores decreased with higher levels of intellectual abilities. Least Squares Mean is actually an adjusted mean change from baseline.	Baseline and 12 weeks
Secondary	Change From Baseline in Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Total Score After 12-week Treatment	Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) is a rating scale used to assess basic and instrumental activities of daily living. In the full version of the scale, 23 items are rated by the investigator using information supplied by the caregiver. Each item has a score range varying from 0-3 to 0-5. The sum score can range from 0 to 78. Higher scores indicate better function. Least Squares Mean is actually an adjusted mean change from baseline.	Baseline and 12 weeks
Secondary	Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Total Score After 12-week Treatment	The CDR-SB is obtained through semi-structured interviews of patients and informants, and cognitive functioning was rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Each domain was rated on a 5-point scale of functioning as follows: 0-no impairment; 0.5-questionable impairment; 1-mild impairment; 2-moderate impairment and 3-severe impairment. Only personal care was scored on a 4-point scale without a 0.5 rating available. The higher the score, the greater the severity of dementia. Least Squares Mean is actually an adjusted mean change from baseline.	Baseline and 12 weeks
Secondary	Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11) Total Score After 12-week Treatment	Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog11) is an 11-item cognitive subscale that objectively measures memory, language, orientation, and praxis with a total score range of 0 to 70. The greater the dysfunction, the greater the score. Least Squares Mean is actually an adjusted mean change from baseline.	Baseline and 12 weeks

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