The use of a food for special medical purposes (product ID 4804/4805) in patients with early Alzheimer’s Disease.

Completed

Conditions: Alzheimer Disease

Registration Number: NL-OMON22420

Lead Sponsor: umico Research B.V.

Brief Summary: Efficacy of a medical food in mild Alzheimer’s disease: A randomized, controlled trial. Alzheimer’s & Dementia 6 (2010) 1–10. Philip Scheltensa,*, Patrick J. G. H. Kamphuisb, Frans R. J. Verheyc, Marcel G. M. Olde Rikkertd, Richard J. Wurtmane, David Wilkinsonf, Jos W. R. Twiskg, Alexander Kurzh. EFFICACY OF A MEDICAL FOOD ON COGNITION IN ALZHEIMER’S DISEASE: RESULTS FROM SECONDARY ANALYSES OF A RANDOMIZED, CONTROLLED TRIAL. J Nutr Health Aging. 2011 15(8):720-4 P.J.G.H. KAMPHUIS, F.R.J. VERHEY, M.G.M. OLDE RIKKERT, J.W.R. TWISK, S.H.N. SWINKELS, P. SCHELTENS Effect of a medical food on Body Mass Index and activities of daily living in patients with Alzheimer’s disease: secondary analyses from a randomized, controlled trial. J Nutr Health Aging. 2011 15(8), 672-676. P.J.G.H. kamphuis, F.R.J. verhey, M.G.M. Olde Rikkert, J.W.R. Twisk, S.H.N. Swinkels, P. Scheltens.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 214

Inclusion Criteria

1. Out-patients, age >= 50 yrs;

2. Diagnosis of probable Alzheimer Disease according to the NINCDS-ADRDA criteria;

Exclusion Criteria

1. Vascular dementia;

2. History, or expected need during the study of cholinesterase-inhibitors or NMDA-receptor antagonists or medications with cholinergic or anticholinergic side effects;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive Performance at 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Cognitive Performance at other time points in study. Behaviour, functional abilities, Quality of Life and blood parameters. All outcome parameters will be evaluated using validated interviews and tests.