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Multiple Nutritional Deficiencies Causing Dementia of the Alzheimer Type (ALZ-vit)

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ClinicalTrials.gov Identifier: NCT01479855
Recruitment Status : Unknown
Verified November 2013 by Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : November 28, 2011
Last Update Posted : November 27, 2013
Sponsor:
Collaborator:
South Eastern Area Health Service
Information provided by (Responsible Party):
Oslo University Hospital

Brief Summary:

The purpose of the study is to compare the concentrations of Vitamin B1 (thiamine), Vitamin B6 (pyridoxal-5-phosphate), folate, Vitamin B12 (cobalamin), Vitamin C (ascorbic acid), Vitamin A (retinol), Vitamin E (alfa-tocopherol), homocystein, uric acid, F2 8-α-isoprostane, 8-deoxyguanosine, retinoids, tau-protein and β-amyloid in spinal fluid, metabolomics, proteomics, m-RNA for DNA repair enzymes and DNA in patients who suffer from mild cognitive impairment (MCI) or mild dementia of Alzheimers type, with healthy controls.

A second aim is to explore the association between vitamin and nutrient reductions, if any, and cognitive function as well as vascular score and possible changes in the MRI.


Condition or disease
Mild Cognitive Impairment Alzheimers Disease

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Multiple Nutritional Deficiencies Causing Dementia of the Alzheimer Type
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Patients
Patients referred to a memory clinic due to memory problems and their healthy spouse



Primary Outcome Measures :
  1. Vitamin A [ Time Frame: Up to 4 weeks after inclusion ]
    The concentration of Vitamin A = Retinol (1.4-3.4 mmol/l) will be measured in serum from patients and healthy controls, and compared.

  2. Vitamin B1 [ Time Frame: Up to 4 weeks after inclusion ]
    The concentration of Vitamin B1 = Thiamin diphosphate (55 - 126 nmol/l) will be measured in blood from patients and healthy controls, and compared.

  3. Vitamin B6 [ Time Frame: Up to 4 weeks after inclusion ]
    The concentration of Vitamin B6 = Pyridoxal-5 phosphate will be measured in serum from patients and healthy controls and compared.

  4. Vitamin B12 [ Time Frame: Up to 4 weeks after inclusion ]
    The concentration of Vitamin B12 = Cobalamin (140-600 pmol/l) will be measured in serum from patients and healthy controls, and compared.

  5. Vitamin C [ Time Frame: Up to 4 weeks after inclusion ]
    The consentration of Vitamin C - Ascorbic acid (45-92 mmol/l) will be measured in serum of patients and healthy controls, and compared.

  6. Vitamin E [ Time Frame: Up to 4 weeks after inclusion ]
    The concentration of Vitamin E = Alfa-tocopherol (16 - 36 mmol/l)will be measured in serum from patients and healthy controls, and compared.


Secondary Outcome Measures :
  1. Cognitive function [ Time Frame: The cognitive testing will be performed between 0 to 4 weeks before the blood samples and spinal fluid is collected. ]
    The assessment of the cognitive function of patients as well as healthy controls will be done according to a comprehensive test battery used in Memory Clinics in Norway that concists of MMSE-NR, Clock-drawing-test and Ten-Word-Test (CERAD), TMTA and B, Abstract thinking, Boston Naming Test and FAS-COWA.


Biospecimen Retention:   Samples With DNA
Whole blood, serum, urine, cerebrospinal fluid


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients referred consequtively to the Memory Clinic, Oslo University Hospital, Ullevål
Criteria

Inclusion Criteria:

  • Cognitive impairment with a MMSE score of 24 or better.
  • Depression score below 9 both on MADRS and Cornell.

Exclusion Criteria:

  • Acute or chronic disease with CRP above 10.
  • Lewy Body Dementia or Frontal Lobe Dementia.
  • Dementia due to a known brain vascular disturbance, hemorrhage or thrombosis.
  • Patients who had not stopped their intake of vitamins and food additives the last four weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479855


Contacts
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Contact: Ingun D Ulstein, MD PhD 95700025 ext +47 ingun.ulstein@aldringoghelse.no
Contact: Thomas Bøhmer, MD PhD t.bohmer@medisin.uio.no

Locations
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Norway
OsloUH, Ullevål Recruiting
Oslo, Norway, 0424
Principal Investigator: Ingun D Ulstein, MD PhD         
Sponsors and Collaborators
Oslo University Hospital
South Eastern Area Health Service
Investigators
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Principal Investigator: Ingun D Ulstein, MD PhD Oslo University Hospital
Publications:
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Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01479855    
Other Study ID Numbers: 2011/698 (REK)
Other Identifier ( Other Identifier: 2005199 Health South-East Trust )
First Posted: November 28, 2011    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013
Keywords provided by Oslo University Hospital:
Mild Cognitive Impairment (MCI)
Alzheimers disease
Vitamines
Nutrients
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Malnutrition
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Nutrition Disorders