Changes in ADAS-cog and ADCS-ADL scores will be compared between the 800 mg BID treatment group and the placebo group in order to determine whether treatment with 800 mg of MPC-7869 slows the rate of disease progression as measured by cognition and…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the change in cognition and activities of daily living, as measured
by ADAS-cog, and ADCS-ADL in subjects with Alzheimer*s disease treated with
MPC-7869.
Secondary outcome
To assess changes in cognition as measured by a Neuropsychological Test Battery
(NTB).To assess changes in global function as measured CDR-sb.
PC-7869.
Safety of treatment with MPC-7869; Cerebrospinal fluid (optional) and
peripheral blood analysis for potential biomarkers; Population pharmacokinetics
of MPC-7869.
Background summary
The hypothesis to be tested is that treatment with MPC-7869 at a well tolerated
dose of 880 mg BID will slow the functional decline in subjects with mild
dementia of the Alzheimer's type as measured by standard instruments including
ADAS-cog, ADCS-ADL, NTB and CDR-sb.
Study objective
Changes in ADAS-cog and ADCS-ADL scores will be compared between the 800 mg BID
treatment group and the placebo group in order to determine whether treatment
with 800 mg of MPC-7869 slows the rate of disease progression as measured by
cognition and activities of daily living compared to placebo.
Study design
This is a multinational, randomized, double blind, placebo controlled, parallel
group study comparing the safety and efficacy of daily dosing of 800 mg twice
daily MPC-7869 to placebo. Study subjects will be stratified at randomization
according to use/nonuse of acetylcholinesterase inhibitors and/or memantine,
and treated for 18 months.
Intervention
Lichamelijk onderzoek, electrocardiogram, laboratorium- evaluatie,
beoordelingsinstrumenten voor patiënten, beoordelingsinstrumenten voor
zorgverleners, optioneel een lumbale punctie en een DNA staal afgifte.
Studie medicatie: willekeurige indeling in een van de twee onderzoeksgroepen.
Een groep die 1600 mg MPC-7869 krijgen of in een groep die placebo krijgen.
Toediengsvorm: 2 maal daags twee tabletten.
Study burden and risks
Blood sampling takes place in week 1, visit at the end of month 1, month 3, 6,
9, 12, 15, 18, 19 (during follow-up visit). Optional are lumbar punctions at V2
and V9. 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.
In 8 of the 10 visits detailed interviews and tests will be taken to judge
mental capacity, daily activities and general functioning.
It*s possible that patients who undergo a lumbar punction get a headache which
is lasting for hours until several days, some will get lower back pain after
the punction is done and other possible side effects are: sickness, bleedings
and nerve root injuries.
320 Wakara Way
Salt Lake City, Utah 84108
US
320 Wakara Way
Salt Lake City, Utah 84108
US
Listed location countries
Age
Inclusion criteria
1. 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.
2. 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.
3. Have a screening MMSE score >=20 and <=26.
4. 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).
5. Subjects must have a reliable caregiver who can read, understand and speak English, Dutch, Danish, Flemish, French, German, Italian, Spanish or Swedish, and, will accompany the subject to each clinic visit, and is willing to sign the Caregiver Assent Form. Caregiver must either live with the subject or see them on at least 4 days per week, with contact sufficient to insure meaningful assessment of changes in subject behavior with time, and must be prepared to verify daily compliance with study medication.
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 | EUCTR2006-000654-43-NL |
| CCMO | NL12526.029.06 |