Effect of LY450139, a g-Secretase Inhibitor, on the Progression of Alzheimer?s Disease as Compared with Placebo. - ND
- Conditions
- Patients with mild or moderate probable AD.MedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease
- Registration Number
- EUCTR2008-002758-39-IT
- Lead Sponsor
- ELI LILLY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1100
[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
[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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method