An open label evaluation of the safety and efficacy of nilvadipine in mild to moderate Alzheimer's Disease - St. James's Hospital Nivadil Trial

Active, not recruiting

• Conditions: Alzheimer's disease

• Registration Number: EUCTR2005-002744-25-IE
• Lead Sponsor: Roskamp Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-11
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 150

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 < 27 and CDR-SB score between 1 and 2.
4. Health: vision and hearing (corrective lenses and hearing aid permissible) sufficient for compliance with testing procedures.
5. A collateral informant such as a spouse, family member, close friend, etc. The informant must have daily contact with the subject and agree to monitor/manage study drug adherence, observe for possible adverse events, assist with psychometric measures requiring informant information, and accompany the subject to all evaluation visits. The subject’s collateral or designee will record blood pressure measurements each day.
6. Fluency in relevant language sufficient to reliably complete all study assessments.
7. Prior brain imaging (CT or MRI) scan consistent with a diagnosis of Alzheimer’s Disease.
8. Systolic BP 120+ and a diastolic BP of 75+.

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified