Effect of ?-Secretase Inhibition on the Progression of Alzheimer’s Disease: LY450139 versus Placebo

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1500

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 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]A magnetic resonance imaging (MRI) or computerized tomography (CT) scan within the past 2 years has confirmed no findings inconsistent with a diagnosis of AD[6]Is at least 55 years old. If female, must be post-menopausal (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

1]Meets National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
[2]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.
[3]Is not capable of swallowing whole oral medications
[4]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 years
[5]Has a history within the past 5 years of a serious infectious disease affecting the brain, including neurosyphilis, meningitis, or encephalitis
[6]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 (PSA) post resection
[7]Has compromised renal function at Visit 1, as determined by creatinine clearance <30 mL/min based on Cockcroft-Gault calculation of creatinine clearance
[8]Has a history of chronic alcohol or drug abuse or dependence (using
DSM-IV TR criteria) within the past 5 years
[9]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;
see Section 6.3.2.2 for details on use of QTc for exclusion).
[10]Has evidence of significant active cardiac disease, uncontrolled hypertension, uncompensated congestive heart failure, or endocarditis
[11]Has potassium <3.2 mEq/L at Visit 1
[13]Has absolute lymphocyte count <0.5 GI/L at Visit 1
[14]Has platelets <75 GI/L at Visit 1
[15]Has a known history of HIV
[16]Has a history of clinically significant multiple or severe drug allergies
[17]At Visit 1, has alanine transaminase (ALT/SGPT) values =2 times the upper limit of normal (ULN) of the performing laboratory, aspartate transaminase (AST/SGOT) values =3 times the ULN, or total bilirubin values =2.0 times the ULN
[18]Requires or is expected to require use of excluded drugs during the study, in particular specific calcium-channel blockers, immune modulators, or immunosuppressants that are excluded from use in this tr

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

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