To evaluate the effect of Souvenaid® on cognition in patïents with mild cognitive impairment after 24 months.
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in cognitive function between patients in the Souvenaid group and
the placebo group on the Dutch translation of the CERAD 10-word list learning,
CERAD 10-word delayed recall, CERAD 10-word recognition, category fluency and
letter digit substitution test.
Secondary outcome
- progression to fulfill the criteria for dementia
- other cognitive domains based on the modified neuropsychological test battery
- plasma levels of EPA, DHA, HDL-cholesterol, LDL-cholesterol
- CSF fatty acid profile
- atrophy rates on MRIs
- functional abilities / clinical global impression (CDR sum of boxes)
- cognitive impairment severity (CDR total score)
- scores on the individual NTB tests.
Exploratory outcome:
- cognitive performance (measured by Mini-Mental State Examination (MMSE) and
the 13-item Alzheimer*s Disease Assessment Scale * Cognitive (ADAS-Cog)
- functional abilities (ADCS-ADL)
- occurrence of depressive symptoms measured with Montgomery Åsberg Depression
Rating Scale (MADRS)
- plasma biomarkers Abeta 1-40, Abeta 1-42, triglycerides, 24 and
27-hydroxycholesterol, total cholesterol, isoprostane, IL-1, IL-6, TNF-a
- fatty acid profile in erythrocyte membranes
- CSF Abeta 1-40 and Abeta 1-42, tau, and phospho-tau, 24 and
27-hydroxycholesterol, isoprostane, IL-1, IL-6, TNF-a
- nutritional/anthropometric parameters
Background summary
Alzheimer's Dementia (AD) is one of the most common neurodegenerative
disorders. Prior scientific research has indicated a clear link between
nutrition and AD. For example omega-3 fatty acids, some vitamins and
antioxidants are associated with a reduced risk of developing AD. Souvenaid® is
a drink which contains Fortasyn* Connect, a specific combination of nutrients.
A proof of concept study with Souvenaid® in mild AD patients demonstrated
improved memory performance after 12 weeks. The product was safe and well
tolerated.
Study objective
To evaluate the effect of Souvenaid® on cognition in patïents with mild
cognitive impairment after 24 months.
Study design
24 month randomized controlled double-blind parallel-groep multicentre trial.
Approximately 300 subjects at five sites will be randomized for this study. If
subjects are willing to continue in the trial, they can prolong participation
four times with a 12 months extension study.
Study burden and risks
In a prior proof of concept study Souvenaid® was safe and well tolerated. In
patients with mild AD the use of Souvenaid® had a positive effect on cognitive
functioning. At the moment there is no therapy for patients with mild cognitive
impairment, but in this patients the use of Souvenaid® might also have a
positive effect on cognitive functioning. Lumbar punction is safe and usually
well tolerated. Collection of CSF samples may be accompanied by post-lumbar
puncture headache in less than 5 % of the patients, this complication is
reversible and usually self-limiting. Other complications such as bleeding or
infection have been described but are very uncommon. The investigation of
biomarkers in CSF is on the other hand very important in understanding the
underlying pathology and the possible working mechanism of the studyproduct.
Venepuncture for collecting blood samples might cause bruising.
Postbus 7057
Amsterdam 1007 MB
NL
Postbus 7057
Amsterdam 1007 MB
NL
Listed location countries
Age
Inclusion criteria
Patients between 55 and 85 years old with episodic memory disorder AND one of the following:
- cerebrospinalfluid beta amyloid 1-42/1-40 < 1 and/or T-tau > 350 pg/ml and/or phospho-tau > 60 pg/ml OR
- MRI evidence for medial temporal lobe atrophy OR
- abnormal FDG PET compatible with AD type changes
Exclusion criteria
- dementia (according to DSM-IV criteria)
- use of omega-3 preparations or high dose vitamins
- historical use of cholinesterase inhibitors of NDMA antagonists
- concomitant serious disease
- major depressive disorder
- participation in any other clinical trial last 30 days
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 |
|---|---|
| CCMO | NL27661.029.09 |