| - candidate number | 5433 |
| - NTR Number | NTR1705 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 9-mrt-2009 |
| - Secondary IDs | Protocol Number 1/090129 The European LipiDiDiet Consortium |
| - Public Title | LipiDiDiet Trial. |
| - Scientific Title | Medical Nutrition in prodromal Alzheimer's Disease, a double-blind controlled 24-month study. |
| - ACRONYM | LipiDiDiet Trial |
| - hypothesis | Dietary 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) studied | Prodromal Alzheimer's Disease |
| - Inclusion criteria | 1. 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 criteria | 1. 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 received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-mrt-2009 |
| - planned closingdate | 1-mrt-2013 |
| - Target number of participants | 300 |
| - Interventions | Duration 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 outcome | Cognitive Performance during 24 months of intervention as measured by a modified version of the NTB (Harrison et al). |
| - Secondary outcome | 1. 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. |
| - Timepoints | Screening, baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months. |
| - Trial web site | www.lipididiet.eu |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | PhD, Professor T. Hartmann |
| - CONTACT for SCIENTIFIC QUERIES | MD, PhD, Professor H. Soininen |
| - Sponsor/Initiator | The European LipiDiDiet Consortium |
| - Funding (Source(s) of Monetary or Material Support) | European Community |
| - Publications | N/A |
| - Brief summary | In 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 5 centres in Sweden (2x), Finland, Germany and the Netherlands. |
| - Main changes (audit trail) | |
| - RECORD | 9-mrt-2009 - 14-sep-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl