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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: |
EUCTR2008-002758-39-IT |
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Date of registration:
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19/03/2009 |
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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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Effect of LY450139, a g-Secretase Inhibitor, on the Progression of Alzheimer?s Disease as Compared with Placebo. - ND
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Scientific title:
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Effect of LY450139, a g-Secretase Inhibitor, on the Progression of Alzheimer?s Disease as Compared with Placebo. - ND |
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Date of first enrolment:
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04/04/2009 |
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Target sample size:
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1100 |
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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:2008-002758-39 |
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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: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: yes
Other specify the comparator: - same IMP used at different dosage
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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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Bulgaria
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France
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Germany
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Hungary
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Italy
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Portugal
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Contacts
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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 a Modified Hachinski Ischemia Scale score of 4 [3] Has an MMSE score of 16 through 26 at Visit 1 [4] Has a Geriatric Depression Scale (GDS) score of 6 (on the staff-administered short form) [5] Has a magnetic resonance imaging (MRI) or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD. Results of this MRI or CT are to be on file at the site. If a patient has not had a prestudy MRI/CT scan in the past 2 years or if attempts to obtain historical imaging results are unsuccessful, a screening non-contrast head CT is to be performed; due diligence to obtain offsite results should be documented in the patient`s file prior to obtaining a screening non-contrast head CT scan. [6] Is at least 55 years old. If female, must be postmenopausal (as evidenced by a lack of menstruation for at least 12 consecutive months or by having had a bilateral oophorectomy).
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:
[7] Meets National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l`Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia [8] Does not 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. [9] Is not capable of swallowing whole oral medications [10] Has serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator?s opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of <2 more years [11] Has a history within the past 5 years of a serious infectious disease affecting the brain, including neurosyphilis, meningitis, or encephalitis [12] Has a history within the past 5 years of a primary or recurrent malignant disease, with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post resection [13] Has compromised renal function at Visit 1, as determined by creatinine clearance 30 mL/min based on Cockcroft-Gault calculation of creatinine clearance: Men: (140 - age) x (weight in kg) -or- (140 - age) x (weight in kg) 72 x (serum creatinine in mg/100 mL) 0.81 x (serum creatinine in mol/L) Women: (either of above formulas) x 0.85 [14] Has a history of chronic alcohol or drug abuse or dependence (using DSM-IV TR criteria) within the past 5 years [15] Requires the use of concomitant medications that prolong the QT/QTc interval or has a known history of Long QT Syndrome or Brugada Syndrome. Has ECG abnormalities obtained at Visit 1 or at predose Visit 2 (baseline value) that, in the opinion of the investigator, are clinically significant with regard to the patient?s participation in the study; or has a QTc abnormality at Visit 1 or predose Visit 2 (baseline value) as indicated by a mean QTc interval >458 ms if male or >474 ms if female (calculate QTc using Bazett?s correction method). [16] Has evidence of significant active cardiac disease, uncontrolled hypertension, uncompensated congestive heart failure, or endocarditis [17] Has potassium <3.2 mEq/L at Visit 1 [18] Has absolute lymphocyte count <0.5 GI/L at Visit 1 [19] Has platelets <75 GI/L at Visit 1 [20] Has a known history of HIV [21] Has a history of clinically significant multiple or severe drug allergies. (See protocol p. 27-28).
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 mild or moderate probable AD.
MedDRA version: 9.1
Level: LLT
Classification code 10001896
Term: Alzheimer's disease
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Intervention(s)
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Product Name: LY450139
Product Code: LY450139
Pharmaceutical Form: Tablet
CAS Number: 425386-60-3
Current Sponsor code: LY450139
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
Product Name: LY450139
Product Code: LY450139
Pharmaceutical Form: Tablet
CAS Number: 425386-60-3
Current Sponsor code: LY450139
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: LY450139
Product Code: LY450139
Pharmaceutical Form: Tablet
CAS Number: 425386-60-3
Current Sponsor code: LY450139
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
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Primary Outcome(s)
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Primary end point(s): The primary objective will be assessed using a mixed-model repeated measures (MMRM) analysis of 2 coprimary outcomes, the Alzheimer?s Disease Assessment Scale?Cognitive subscore (ADAS-Cog11) and the Alzheimer?s Disease Cooperative Study?Activities of Daily Living Inventory (ADCS-ADL), in which the specific hypothesis is that the change at the end of the initial treatment phase for LY450139 will be significantly less than that for placebo.
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Secondary Objective: The secondary objectives of the study are: 1) to test the hypothesis that LY450139 is a disease-modifying medication independent of acute symptomatic effects; 2) to provide supporting evidence that LY450139 is a disease-modifying compound; 3) to compare the safety of LY450139 and placebo; 4) to characterize population pharmacokinetics (PK) of LY450139, explore potential factors that may influence variability of PK, and explore the association of PK variables with efficacy, biomarkers, and safety parameters; 5) to test the hypothesis that LY450139 will slow the decline of AD, compared with placebo, using 2 extended versions of the Alzheimer?s Disease Assessment Scale (a 12-item version, the ADAS-Cog12, and a 14-item version, the ADAS-Cog14), assessed using MMRM analysis; 6) to assess global clinical benefit of treatment with LY450139 using the CDR-SB, NPI and other clinical intstruments; (see amended protocol, p. 15-17)
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Main Objective: The primary objective of this study is to test the hypothesis that LY450139 given orally will slow the decline associated with Alzheimer? Disease (AD) as compared with placebo
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Secondary ID(s)
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H6L-MC-LFBC
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2008-002758-39-DE
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 20/01/2009
Contact:
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