EUCTR2012-002764-27-GRActive, not recruitingPhase 1
A European multicenre double-blind placebo controlled phase III trial of nilvadipine in mild to moderate Alzheimer's disease. - NILVAD
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- St James's Hospital
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Age range: Adult subjects, males and females over age 50 years.
- •2.Subjects with a diagnosis of probable Alzheimer’s disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s disease and Related Disorders Association, Inc (NINCDS-ADRDA) criteria (McKhann et al, 1984)
- •3. Subjects with a Standardised Mini-Mental State Examination (SMMSE) (Standish & Molloy, 1991) score of greater than or equal to 12 and less than 27.
- •4.Subjects on a stable dose (>3 months) of cholinesterase inhibitor or memantine. The dose must be stabilised prior to randomisation. Patients due to begin these medications must not be enrolled until the dose is stabilised. Subjects who are not on cholinesterase inhibitors or memantine due to poor tolerability and/or who will not require treatment with these medications during the course of the study can be included .
- •5.Subjects who retain capacity will provide written informed consent for participation. The procedure for obtaining informed consent when the subject has reduced decision making capacity will follow national law and will be assessed by the relevant bodies in each of the participating countries.
- •6.Fluency in relevant language sufficient to reliably complete all study assessments.
- •7. Subjects with blood pressure values greater than 100/65mmHg but less than 159/99mmHg (Grade 1 hypertension, ECS guidelines 2007; escardio.org/guidelines) using an office based BP measurement will be included, or subjects with blood pressure values greater than 105/70mmHg but less than 140/90mmHg using an Ambulatory BP measurement will be included.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
Exclusion Criteria
- •1. Subjects with co-morbid dementia due to other neurological disorders such as Parkinson's disease, vascular dementia, Huntington's disease, Pick's disease, Creutzfeldt-Jakob disease, normal pressure hydrocephalus, brain tumour, 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 neurological deficits, known structural brain abnormalities, or any other condition known to interfere with cognitive function.
- •2. Subjects currently taking any calcium channel blocker or beta-blocker.
- •3. Subjects who in the opinion of the investigator, have a medical condition that would preclude them from participating in the study:
- •e.g. chronic heart failure, syncope within the past year, significant valvular heart disease i.e. severe aortic and mitral stenosis symptomatic orthostatic hypotension within the last year, or subjects requiring more than one agent to control BP etc. Any subject with significant cardiovascular disease including recent history of acute myocardial infarction and unstable angina pectoris.
- •Subjects who in the opinion of the investigator are unlikely to complete per protocol due to care issues etc.
- •4.Current Axis I diagnosis of schizophrenia, bipolar disorder, major depression. Subjects who are currently or who have within the past year met criteria for drug or alcohol abuse or dependence.
- •5.Pregnant women or women who may possibly become pregnant (pre-menopausal). Female subjects must be postmenopausal (no menses for = 12 months without an alternative medical cause) to participate in the study.
- •6.Female subjects who are breastfeeding will be excluded from the study
- •7. Subjects with a history of hypersensitivity to nilvadipine (Nivadil).
- •8.Subjects who have taken an investigational or other unapproved drug during the 30 days or five half-lives, whichever is longer, prior to baseline.
- •9. Subjects who are taking any medication listed in the list of exclusion medication for the study.
- •10. Subjects with abnormal ECG results which prevent participation in the study.
- •11. Standardised Mini-Mental State Examination (SMMSE) score of less than 12 or greater than 26.
- •12. Subjects who are participating in other clinical research studies.
- •13. Subjects with any clinically significant laboratory blood test abnormality on his/her screening test.
- •14. Patients with sigificant renal insuffiency (estimated glomerular filtration rate : eGFR <30ml/min)will be excluded .
- •15. Subjects with severly impaired hepatic function (liver cirrhosis)will be excluded.
- •16. Subjects with blood pressure values less than 100/65mmHg or greater than 159/99mmHg (Grade 1 hypertension, ECS guidelines 2007; escardio.org/guidelines) using an office based BP measurement will be excluded or subjects with blood pressure values less than 105/70mmHg or greater than 140/90mmHg using an Ambulatory BP measurement will be excluded.
- •17.Subjects with clinically significant abnormalities in their CT/MRI results which would prevent inclusion in the study.
Investigators
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