Medical Nutrition in prodromal Alzheimer's Disease, a double-blind controlled 24-month study, with four times a 12 month extension study.

Medical Nutrition in prodromal Alzheimer's Disease, a double-blind controlled 24-month study, with four times a 12 month extension study. - LipiDiDiet

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43619

Enrollment

Registered

2009-07-09

Start date

2010-02-08

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild cognitive impairment prodromal Alzheimer Disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients between 55 and 85 years old with episodic memory disorder AND one of the following: - cerebrospinalfluid beta amyloid 1-42/1-40 350 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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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 Alzheimers 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	—

Measure

Time frame

- 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

—

Countries

Netherlands

Outcome results