Effects of LY450139, on the Progression of Alzheimer´s Disease as Compared With Placebo IDENTITY-2
- Conditions
- -F00F00
- Registration Number
- PER-162-08
- Lead Sponsor
- ELI LILLY AND COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Meets the criteria for probable AD of the National Institute of Neurological and Communication Disorders and Stroke / Association of Alzheimer´s Patients and Related Disorders (NINCDS / ADRDA).
• Has a score <4 on the Modified Hachinski Ischemia Scale
• Has an MMSE score of 16 to 26 on Visit 1
• Has a score <6 on the Geriatric Depression Scale (GDS) (on the short form administered by the staff).
• You have a magnetic resonance imaging (MRI) or computed tomography (CT) scan done within the last 2 years that has been confirmed without results inconsistent with a diagnosis of AD. The results of this MRI or CT must be archived in the center. If a patient has not had an MRI / CT before the study in the last 2 years or attempts to obtain results of historical images are not successful, then a head CT should be performed without contrast of selection; the safeguards due to obtain the results outside the center must be documented in the patient´s file prior to obtaining a head CT without contrast of selection.
• You are at least 55 years old. If you are a woman, you must be post-menopausal, (evidenced by absence of menstruation for at least 12 consecutive months or for having had a bilateral oophorectomy.
• Meets the criteria for vascular dementia of the National Institute of Neurological Disorders and Stroke / International Association for Research and Teaching in Neurosciences (NINDS / AIREN)
• You do not have a reliable caregiver who is frequently in contact with the patient (defined for at least 10 hours a week), who accompanies the patient to the consultation and / or is available by phone at designated times and who will monitor the administration of prescribed medications Note: The caregiver must be able to communicate with the center staff and be willing to comply with the requirements of the protocol and that in the opinion of the researcher must have an adequate educational level to complete the specific questionnaires of the protocol. Participants who are living in a nursing home can also be included if the intake of the study medication is supervised and if regular contact is maintained with a caregiver who accompanies the patient.
• Not able to swallow whole medications.
• Have serious or unstable diseases including liver, kidney, gastroenterological, respiratory, cardiovascular (including ischemic), endocrinological, neurological (other than AD), psychiatric, immunological, or hematological disease or other conditions that, in the opinion of the researcher , could interfere with safety and efficacy analyzes in this study or have a life expectancy <2 years
• Has a history within the last 5 years of serious infectious disease that affects the brain, including neurosyphilis, meningitis or encephalitis
• Has a history within the last 5 years of primary or recurrent malignant disease with the exception of squamous cell carcinoma removed in situ, basal cell carcinoma, cervical carcinoma in situ, or prostate cancer in situ with a specific prosthetic antigen normal post resection
• Has a compromised renal function on Visit 1, determined by a creatinine clearance <30 mL / min based on the calculation of Cockcroft-Gault creatinine clearance
• Has a history of drug or chronic alcohol abuse or dependence within the past 5 years (using the DSM-IV TR criteria).
• Requires the use of concomitant medications that prolong the QT / QTc interval or have a known history of long QT syndrome or Brugada syndrome. Has abnormal ECGs obtained in Visit 1 or Visit 2 predose (baseline value) that in the opinion of the investigator are clinically significant with respect to the participation of the patient in the study; or has a QTc abnormality at Visit 1 or Visit 2 predose (baseline) as indicated by an average QTc interval> 458 ms in men or> 474 in women. (See Section 6.3.2.2 for details on the use of QTc for exclusion.)
• You have evidence of significant active heart disease, uncontrolled hypertension, decompensated congestive heart failure or endocarditis.
• Has a potassium level <3.2 mEq / L in Visit 1
• Has an absolute lymphocyte count <0.5 GI / L on Visit 1
• Has platelets <75 GI / L in Visit 1
• Has a known history of HIV
• Has a history of clinically significant multiple or severe drug allergies
• In Visit 1, it has alanine transaminase (ALT / SGPT) values> 2 times the upper limit of normal (ULN) of the laboratory performing the analysis, aspartate transaminase (AST / SGOT) values> 3 times the ULN, or total bilirubin values> 2.0 times the ULN
• Requires or is expected to require the use of drugs excluded during the study, in particular calcium channel blockers, specific immunom
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method