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van CCT (UK)

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LipiDiDiet Trial.

- candidate number5433
- NTR NumberNTR1705
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mrt-2009
- Secondary IDsProtocol Number 1/090129 The European LipiDiDiet Consortium
- Public TitleLipiDiDiet Trial.
- Scientific TitleMedical Nutrition in prodromal Alzheimer's Disease, a double-blind controlled 24-month study with one, two, three and four 12 month Extension studies
- ACRONYMLipiDiDiet Trial
- hypothesisDietary management of nutrient deficiencies with the medical food under study has a positive effect on cognitive performance in patients with prodromal Alzheimer's Disease.
- Healt Condition(s) or Problem(s) studiedProdromal Alzheimer's Disease
- Inclusion criteria1. Prodromal AD as defined by episodic memory disorder and evidence for underlying AD pathology (Dubois et al 2007);
2. Age 55 - 85 years;
3. MMSE >= 20;
4. Written informed consent;
5. Availability of a responsible caregiver.
- Exclusion criteria1. Dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV);
2. Use of omega-3 preparations;
3. Historical use of AD medication;
4. Alcohol or drug abuse;
5. A concomitant serious disease;
6. Major depressive disorders (DSM-IV);
7. Intake of specific (doses) of nutritional supplements;
8. Participation in any other clinical trial in the last 30 days;
9. Subjects with MRI scan consistent with a diagnosis of stroke, intracranial bleeding, mass lesion or NPH.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate1-mrt-2013
- Target number of participants300
- InterventionsDuration of intervention: 24 months
Intervention group: all participants in the intervention group will receive daily 125 ml of Souvenaid®. Souvenaid® is a 125ml (125kcal) once-a-day multi-nutrient drink. Souvenaid® contains FortasynTM Connect [a specific combination of nutrients].
Control group: All participants in the control group will receive daily 125 ml of a control product. The control product is iso-caloric, similar in flavour, appearance, and composition without FortasynTM Connect.
- Primary outcomeCognitive Performance during 24 months of intervention as measured by a modified version of the NTB (Harrison et al).
- Secondary outcome1. Progression to dementia;
2. Cognitive performance (MMSE, 13-item ADAS-Cog);
3. Functional abilities (ADCS-ADL);
4. Occurrence of depressive symptoms (MADRS);
5. Plasma biomarkers;
6. Atrophy rates on MRIs;
7. Nutritional (blood) parameters;
8. Tolerance and safety.
All during 24 months of intervention.
- TimepointsScreening, baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months.
- Trial web
- statusinclusion stopped: follow-up
- CONTACT for SCIENTIFIC QUERIESMD, PhD, Professor H. Soininen
- Sponsor/Initiator The European LipiDiDiet Consortium
- Funding
(Source(s) of Monetary or Material Support)
Extension studies: Nutricia Research as part of LipiDiDiet consortium, European Community
- PublicationsN/A
- Brief summaryIn this trial the efficacy of intervention with a Medical Food on cognitive performance will be compared with a control product in Patients with prodromal Alzheimer’s Disease. The study is performed in 11 centers in Finland (1x), Sweden (1x), the Netherlands (3x) and Germany (6x)
- Main changes (audit trail)- Planned Closing Date (Last Patient Last Visit): 30JUN2015 18-aug-2015: Change titel and summary

Secondary outcome: NEW
- Progression to dementia
- Cognitive performance as measured by modified NTB cognitive domains
- Functional abilities / clinical global impression as measured by CDR Sum of Boxes
- Plasma biomarkers
- Atrophy rates on MRIs
- Nutritional (blood) parameters
- Tolerance and safety
All during 24 months of intervention.

Timepoints: NEW
Extension studies: 30 months, 36 months, 42 months, 48 months, 54 months, 60 months, 66 months, 72 months
- RECORD9-mrt-2009 - 11-mrt-2016

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