A Phase III Trial of Nilvadipine to Treat Alzheimer's Disease (NILVAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02017340|
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : March 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Nilvadipine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||511 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A European Multicentre Double-blind Placebo-controlled Phase III Trial of Nilvadipine in Mild to Moderate Alzheimer's Disease|
|Actual Study Start Date :||April 24, 2013|
|Actual Primary Completion Date :||December 16, 2016|
|Actual Study Completion Date :||December 16, 2016|
Placebo Comparator: Placebo
250 patients will receive the placebo
8mg Placebo tablet taken once a day at lunch time for 78 weeks
Active Comparator: Nilvadipine
250 patient will receive the active drug Nilvadipine 8mg
8mg of Nilvadipine taken once a day at lunch time for 78 weeks
Other Name: Also known as Nilvadil (Brand Name)
- Alzheimer's Disease Assessment Scale (ADAS) Cog [ Time Frame: 18 months ]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.
- Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) [ Time Frame: 18 months ]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.
- Disability Assessment for Dementia (DAD) [ Time Frame: 18 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017340
|Principal Investigator:||Brian Lawlor, Prof||Trinity College Dublin|