Alzheimer's disease (AD) is an ever-increasing public health concern among the aging population and is the most common form of dementia affecting more than 15 million individuals worldwide and around 5 million Europeans. The direct and indirect costs of AD and other dementias amount to more than €440,000 million each year (www.alz.org, 2010). Even modest therapeutic advances that delay disease onset and progression could significantly reduce the global burden of the disease and the level of care required by patients. While there are symptomatic-based drug therapies available for AD, these medications do not prevent the disease process itself. There is therefore an imperative to develop new treatments for AD that have disease modifying effects. This double-blind placebo controlled study will test the efficacy and safety of nilvadipine in 500 subjects with mild to moderate AD over a treatment period of 18 months. There is a strong scientific rationale for this study: Nilvadipine, a licensed calcium channel enhances Aß clearance from brain and restores cortical perfusion in mouse models of AD. Nilvadipine is safe and well tolerated in AD patients and clinical studies with this medication have shown stabilization of cognitive decline and reduced incidence of AD, pointing to both symptomatic and disease modifying benefits. Male and female patients with mild to moderate AD aged between 50 and 90 with a range of medical morbidities and frailty will be included in the study. If this trial is successful, nilvadipine would represent an advance in the treatment of AD patients and would have a major impact on the health and social care costs incurred in Europe by this neurodegenerative disorder. Furthermore, the creation of the NILVAD network will support future clinical trials and research innovation in AD across Europe.
Please see 'Brief Summary', above
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
511
8mg of Nilvadipine taken once a day at lunch time for 78 weeks
8mg Placebo tablet taken once a day at lunch time for 78 weeks
Centre Hospitalier Universitaire d'Amiens (CHU Amiens)
Amiens, France
Centre Hospitalier Universitaire de Bethune (CH Bethune)
Béthune, France
Centre Hospitalier Universitaire de Caen (CHU Caen)
Caen, France
Centre Hospitalier Universitaire de Calais (CHU Calais)
Calais, France
Centre Hospitalier Universitaire de Lens (CHU Lens)
Lens, France
Centre Hospitalier Regional et Universitaire de Lille (CHRU Lille)
Lille, France
Centre Hospitalier Universitaire de Saint Philibert (GHICL)
Lille, France
University of Ulm
Ulm, Germany
"G. Papanicolaou" Hospital
Athens, Greece
"G.Papageorgiou" Hospital
Athens, Greece
...and 13 more locations
Alzheimer's Disease Assessment Scale (ADAS) Cog
The Alzheimer's Disease Assessment Scale (Cognitive) (Mohs et al. 1983) ADAS-cog 12 is a primary efficacy outcome measure, and includes 12 items of cognitive evaluation, namely immediate word recall, naming objects and fingers, commands, constructional praxis, ideational praxis, orientation, word recognition, remembering test instructions, spoken language ability, word-finding difficulty in spontaneous speech, comprehension \& delayed recall. A higher ADAS-cog score indicates a poorer cognitive function.
Time frame: 18 months
Clinical Dementia Rating Scale Sum of Boxes (CDR-sb)
Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) (Morris et al 1993) is the secondary efficacy outcome measure. This is a semi-structured interview with the caregiver and the patient. The patient's performance in the domains of memory, orientation, judgment, problem solving, community affairs, home and hobbies and personal care are assessed. The CDR-sb is scored from 0-18, with the higher score indicated greater impairment.
Time frame: 18 months
Disability Assessment for Dementia (DAD)
Disability Assessment for Dementia (DAD) (Gelinas et al. 1999) is a key secondary efficacy outcome measure and evaluates the basic and instrumental activities in daily activities of elderly people with dementia. This 40-item scale addresses a range of functional domains: eating, meal preparation, telephoning, hygienic, dressing, medication, corresponding, finance, leisure, and housework.
Time frame: 18 months
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