Safety-evaluation in case of long term daily usage of MPC-7869. In this Open Label Study , with regard to the safety of MPC-7869, attention will be paid to the amount of AE*s, the physical examinations of subjects, the research of vital functions,…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety effects: this includes the amount of Adverse events (AE*s), changes at
physical examinations and results of the clinical laboratory tests.
Secondary outcome
N.a.
Background summary
Hypothesis: treatment with MPC-7869, applying to a dose of 800 mgr. BID, will
delay the cognitive and functional decline in case of a mild dementia of the
Alzheimer's type.
Study objective
Safety-evaluation in case of long term daily usage of MPC-7869.
In this Open Label Study , with regard to the safety of MPC-7869, attention
will be paid to the amount of AE*s, the physical examinations of subjects, the
research of vital functions, the taking of ECG*s and the clinical laboratory
tests. (ref. Protocol, page 28, safety; 10.3).
Study design
An Open Label Study into the effect of the daily treatment of MPC-7869 of
subjects with the Alzheimer-type dementia.
All subjects will receive MPC-7869.
Subjects have completed the Myriad MPC-7869 study without protocol violations.
Study burden and risks
Blood sampling takes place every three months, during each clinical visit.
The risks of the patient are the risks of blood sampling, and possible side
effects or undesirable effects of study drugs.
Subjects will undergo a physical examination. An ECG scan will be taken, vital
functions will be registered. Blood sampling will be done for haematological
tests. An urine sample has to be brought along.
The risk of possible side-effects and undesired effects of the study medication
is acceptable, in comparison with existing treatment; this result applies to
the degree that it has been researched. Also considering that there aren*t
many treatment possibilities for this type of patients.
320 Wakara Way
Salt Lake City, Utah 84108
USA
320 Wakara Way
Salt Lake City, Utah 84108
USA
Listed location countries
Age
Inclusion criteria
1. Completed, without protocol violations, a Myriad Pharmaceuticals, Inc MPC-7869 clinical trial for Alzheimer's disease.
2. Have had a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders * Fourth Edition (text revised) (DSM IV [TR]), as described in Appendix B, and meet the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer*s Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer*s disease, as described in Appendix C.
3. Have a computed tomography (CT) or magnetic resonance imaging (MRI) within the past 12 months, demonstrating absence of clinically significant focal intracranial pathology. If no scan is available in the previous 12 months, then a CT or MRI scan will be obtained.
4. Have a screening MMSE score *20 and *26.
5. Have a screening Modified Hachinski Ischaemic score < 4.
6. Men or women ages * 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
7. Subjects must have a reliable caregiver.
Exclusion criteria
1. Current evidence or history in the past 2 years of epilepsy, focal brain lesion, head injury with loss of consciousness and/or immediate confusion after the injuries, or DSM-IV (TR) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
2. History of hypersensitivity to flurbiprofen or other NSAIDs, including COX-2 specific inhibitors.
3. Documented evidence of active gastric or duodenal ulcer disease within the past 3 months.
4. Chronic or acute renal, hepatic or metabolic disorder .
5. Uncontrolled cardiac conditions (New York Heart Association Class III or IV)
6. History of NSAID associated ulcers.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-003362-17-NL |
| CCMO | NL20362.029.07 |