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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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4 January 2022 |
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Main ID: |
EUCTR2009-014424-29-BE |
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Date of registration:
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22/02/2010 |
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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)
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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)
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Date of first enrolment:
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30/06/2010 |
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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: no
Placebo: no
Other: no
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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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Key inclusion & exclusion criteria
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Inclusion criteria:
A patient included in the study must meet all of the following 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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Alzheimer's Disease
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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
Other descriptive name: Semagacestat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 140-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Semagacestat
Product Code: LY450139
Pharmaceutical Form: Tablet
INN or Proposed INN: Semagacestat
Current Sponsor code: LY450139
Other descriptive name: Semagacestat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Semagacestat
Product Code: LY450139
Pharmaceutical Form: Tablet
INN or Proposed INN: Semagacestat
Current Sponsor code: LY450139
Other descriptive name: Semagacestat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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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).
• 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).
• To provide supporting evidence that semagacestat slows the progression of
disease, multiple biomarkers are being assessed in Studies LFAN and LFBC.
For further secondary objectives please see protocol
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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 AEs, vital signs, laboratory evaluations, and electrocardiograms
(ECGs).
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Primary end point(s): Completion of 24 month treatment period
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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: 30/06/2010
Contact:
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