None listed
Conditions
Interventions
Group 1 Type of group
Donepezil 5 mg capsule, orally, once daily, first 14 days of treatment
Group 2 Type of group
Placebo capsule, orally, 84 days of treatment
Sponsors
ASTRAZENECA PERU S.A.,
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Provision of informed consent before the start of any procedure related to the study. Patients deemed unable to provide informed consent may be enrolled if the informed consent of the Legally Acceptable Representative has been obtained in accordance with local regulations. • Clinical diagnosis of probable AD according to the NINCDS-ADRDA criteria. • History of progressive impairment of memory and other cognitive functions for at least 12 months • Hachinski Ischemia Score <4 • Computed Tomography (CT) or Magnetic Resonance Exam (MRI) within the last 6 months (performed after the onset of dementia) consistent with the diagnosis of AD. If the CT / MRJ test is older than 6 months, the patient will need to renew the CT / MRI to confirm the diagnosis. • MMSE score from 16 to 24. • Men and women, 55-85 years, including the day of enrollment • The patient must live with an appropriate caregiver at home, or in a community accommodation. The caregiver should be able to accompany the patient to the visits to the center or attend the study visits in the patient´s case. The same caregiver is needed for visits where ADCS-CGIC is evaluated. • The patient and the caregiver understand and are capable and wish to meet all the requirements of the study, judging by the investigator. • The patient and the caregiver should understand, speak and read the local language. • A body mass index (BMI = weight / height) of 18-35 kg / m2 according to the researcher´s calculations during enrollment.
Exclusion criteria
Exclusion criteria: • Possible, probable or definitive vascular dementia in accordance with the criteria of the National Institute of Neurological Disorders and Stroke Association-Association Internationale pour la Recherche et l´Enseignement en Neurosciences (NINDS-AIREN) • Significant neurological disease or dementia other than AD, for example, mixed dementia, frontotemporal dementia and Parkinson´s disease, which may affect cognition or the ability to complete the study. • Current major depressive disorder or other major psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders Edition (DSM-IV). • Clinically significant or unstable current respiratory disease, gastrointestinal disease, heart disease, cerebrovascular disease, hematological disease, liver disease, kidney disease, urogenital disease, or other major disease, as judged by the researcher. • Current systemic disease that, at the discretion of the researcher, probably impairs or affects the safety of the participant, influences cognitive evaluations or affects the ability to complete the study. • History of seizures or loss of consciousness within 6 months before enrollment. • History of any malignant disease within the last 5 years, with the exception of minor superficial cutaneous disease (ie, basal cell carcinoma and squamous cell carcinoma). • Myocardial infarction or acute coronary syndrome within the last year. • Clinically significant ECG abnormalities according to the investigator´s criteria based on the evaluation by a centrally located experienced cardiologist who interprets the ECG. • Prolonged QTcF> 450 msec or shortened QTcF <350 msec or family history of long QT syndrome. • Clinically significant abnormal findings on the physical examination, vital signs, or clinical biochemistry that may affect the patient´s ability to complete the study procedures, participant safety, or interpretation of data at the investigator´s discretion. • Women of childbearing age (for example, postmenopausal defined as amenorrhea for at least 12 months after cessation of all periods or documentation of irreversible surgical sterilization due to hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but without tubal ligation) • Male patients who plan to have a child or donate sperm within 3 months after the last intake of the study drug. • Known or suspected alcohol and / or drug abuse as defined by the DSM-IV criteria and that is not in complete remission. • Vision or hearing injury that makes cognitive tests difficult as the researcher considers. • Known hypersensitivity to piperidine derivatives. • Previous use of memantine or acetylcholinesterase inhibitors (AchEI). • Use of any potent CYP3A4 or Cyp2D6 enzyme inhibitor or inducer during the last 4 weeks before randomization (see Table 4 for further clarification)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary cognitive functions evaluated include memory, language and practice components. Memory is evaluated by the following items: remember test instructions, guidance, remember words and word recognition. The language is evaluated by aspects such as: ability of spoken language, understanding of spoken language, difficulty finding words, following orders and naming objects and fingers. The practice is evaluated by the practical items of constructions and creation of ideas. Measure:CogState Computerized Neurological Test Battery Timepoints:Tl. of 25 times: 10 times between Days 3-14, 5 times between Days 36-42, 5 times between Days 64-70, four times between Days 92-97, 1 time on Day 98 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Cognitive function will be evaluated using original inversion of 9 items of the NTB (Harrison et al 2007). The NTB index memory and / or executive function and it has been shown that this test class is a sensitive measure of cognitive decline in patients with AD. Measure:Neuropsychological Test Battery (NTB) Timepoints:Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97 ; Outcome name:The 11-item ADAS-Cog has been specifically designed for the evaluation of the severity of major dysfunctions in the characteristic performance of patients with AD. It has been used frequently in pharmacological tests in AD of mild to moderate severity (> 10 MMSE points) and is accepted by the authorities as a validated endpoint for registration tests. Measure:Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Timepoints:Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97 ; Outcome name:The ADCS-CGIC is a standardized method to perform CGtC scores in patients with Alzheimers disease (Schneider et al 1997). It provides a semi-structured format that allows clinical specialists to gather the necessary clinical information from the patient as well as the caregiver in order to make a clinical global impression of change. Measure:Alzheimers Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Timepoints:Tl. of 4 times: Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97 | — |
Countries
Canada, Peru, Poland, South Africa
Contacts
Public ContactMarice Diaz
ASTRAZENECA PERU S.A.
Outcome results
None listed