Alzheimer's disease
Conditions
Interventions
Trade Name: Nivadil
Product Name: Nivadil
Product Code: Nilvadipine
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: Nilvadipine
CAS Number: 75530-68-6
Current Sponsor code: R
Sponsors
Roskamp Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age range: Adult subjects between the ages of 60 and 90 years-old. 2. Sex distribution: both men and women. 3. Prior diagnosis of mild to moderate AD based on NINCDS-ADRDA criteria and an MMSE score > 14 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subjects with co-morbid dementia or other neurologic disorders such as Parkinson's disease, vascular dementia, Huntington's disease, Pick's disease, Creutzfeldt-Jakob disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis, as well as subjects with HIV disease, neurosyphilis, history of significant head trauma with loss of consciousness followed by persistent neurologic deficits, known structural brain abnormalities, or any other condition with known interference with cognitive function. • History of hemodynamically significant coronary artery disease. • History of chronic heart failure. • Syncope within the past year. • History or finding on examination of significant valvular heart disease i.e severe aortic and mitral stenosis. • History or finding on examination of significant outflow tract obstruction i.e loud murmurs on physical exam. • History or finding on examination of hemodynamically significant tachycardia. • History of symptomatic orthostatic hypotension within the last year • Call PI/Medical Monitor for consultation regarding subjects on Cardiac medications including Antiarrhythmics and Digoxin. • Currently taking any calcium channel blocker or other antihypertensive medications for any reason. • Presence of hepatitis B or C antigen or laboratory values of liver enzymes > 2.0 x normal. • Subjects who have been diagnosed with hepatic function disorder to include elevated AST (GOT), ALT (GPT), or ?-GT levels at levels 2x normal. • Current diagnosis of clinical psychopathology such as schizophrenia, bipolar disorder, somataform disorder, etc. • Subjects who are currently or who have within the past year met criteria for drug or alcohol abuse or dependence. • Subjects with suspected incomplete hemostasis following intracranial hemorrhage. • Subjects with elevated intracranial pressure during the acute stage of cerebral stroke. • Pregnant women or women who may possibly become pregnant. • Subjects with a history of hypersensitivity to nilvadipine (Nivadil). • Subjects who have suffered a severe infection or a major surgical procedure within six months prior to screening. • Subjects who have taken an investigational or other unapproved drug during the 30 days or five half-lives, which ever is longer, prior to baseline. • Subjects who are taking or have taken within the past 30 days any of the unacceptable concomitant drugs listed in Appendix C. • Compromised kidney function as assessed by laboratory values (less than 75%) or any condition which would make the subject, in the opinion of the investigator, unsuitable for the study. • Subjects who, in the opinion of the investigator, may not be able to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety and efficacy of nilvadipine and its effects on the serum and plasma levels of the protein beta-amyloid. ;Secondary Objective: To examine the effects of nilvadipine on cerebrovascular and peripheral haemodynamics in patients with Alzheimer’s disease.;Primary end point(s): The primary endpoint of the study will be the completion of study patients on 6 weeks of nilvadipine treatment with cognitive assessment and measurement of serum and plasma levels of beta-amyloid throughout the study. | — |
Countries
Ireland
Outcome results
None listed