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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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21 December 2021 |
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Main ID: |
EUCTR2009-014424-29-IT |
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Date of registration:
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18/03/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Open-Label Extension for Alzheimer?s Disease
Patients Who Complete One of Two Semagacestat
Phase 3 Double-Blind Studies (H6L-MC-LFAN or
H6L-MC-LFBC) - ND
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Scientific title:
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Open-Label Extension for Alzheimer?s Disease
Patients Who Complete One of Two Semagacestat
Phase 3 Double-Blind Studies (H6L-MC-LFAN or
H6L-MC-LFBC) - ND |
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Date of first enrolment:
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12/05/2010 |
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Target sample size:
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1500 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014424-29 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Finland
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France
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Germany
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Italy
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Spain
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Sweden
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
[1] Meets National Institute of Neurological and Communicative
Disorders and Stroke/Alzheimer?s Disease and Related Disorders
Association (NINCDS/ADRDA) criteria for probable AD.
[2] Has completed semagacestat Study LFAN or Study LFBC through
Visit 20.
[3] Must continue to have a reliable caregiver who is in frequent contact
with the patient (defined as at least 10 hours per week), will
accompany the patient to the office and/or be available by telephone at
designated times, and will monitor administration of prescribed
medications. Note: The caregiver must be able to communicate with
site personnel and be willing to comply with protocol requirements,
and in the investigator?s opinion must have adequate literacy to
complete the protocol-specified questionnaires. Participants living in
an assisted-living facility may be included if study medication intake is
supervised and if regular contact with a caregiver who accompanies
the patient is maintained.
[4] Must be capable of swallowing whole oral medications.
[5] Agrees not to participate in studies of any other investigational
compounds for the duration of Study LFBF.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
[6] Meets feeder study discontinuation criteria at the last visit of the feeder
study (Study LFBF Visit 1).
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with Alzheimer?s Disease who Complete One of Two previous studies (H6L-MC-LFAN or
H6L-MC-LFBC)
MedDRA version: 9.1
Level: HLT
Classification code 10001897
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Intervention(s)
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Product Name: Semagacestat
Product Code: LY450139
Pharmaceutical Form: Tablet
INN or Proposed INN: Semagacestat
Current Sponsor code: LY450139
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Product Name: Semagacestat
Product Code: LY450139
Pharmaceutical Form: Tablet
INN or Proposed INN: Semagacestat
Current Sponsor code: LY450139
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Product Name: Semagacestat
Product Code: LY450139
Pharmaceutical Form: Tablet
INN or Proposed INN: Semagacestat
Current Sponsor code: LY450139
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
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Primary Outcome(s)
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Main Objective: The primary objective of the study is to assess the safety of semagacestat in Alzheimer?s
disease patients during 24 months of open-label treatment following completion of up to 21 months of
active treatment in a double-blind registration study (LFAN or LFBC) through analysis of adverse events
(AEs), vital signs, laboratory evaluations, and electrocardiograms
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Primary end point(s): When change from baseline is assessed, patients will be included in the analysis only if both a baseline
and a postbaseline measure are available. The endpoint measure is defined as the patient?s last measure in
the appropriate study period.
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Secondary Objective: To test the hypothesis that semagacestat will continue to slow the cognitive and functional decline
associated with AD during 24 months of open-label treatment, comparing patients treated with
semagacestat for ≤ 6 months with patients treated for 21 months in the feeder studies (LFAN or
LFBC). Cognitive and functional decline will continue to be assessed using the Alzheimer?s Disease
Assessment Scale?Cognitive subscore (ADAS-Cog11) and the Alzheimer?s Disease Cooperative
Study?Activities of Daily Living Inventory (ADCS-ADL).
o To assess the overall clinical benefit of treatment with semagacestat in AD patients during 24 months
of open-label treatment, comparing patients treated with semagacestat for ≤ 6 months with patients
treated for 21 months in the feeder studies (LFAN or LFBC). Overall clinical benefit of treatment
with semagacestat will be assessed through the Clinical Dementia Rating?Sum of Boxes (CDR-SB) (see protocol pp.18-19)
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Secondary ID(s)
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2009-014424-29-FI
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H6L-MC-LFBF
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 09/02/2010
Contact:
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