Multiple Nutritional Deficiencies Causing Dementia of the Alzheimer Type

NCT01479855 | Unknown

• 2 other identifiers: 2011/698 (REK)Other Identifier
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimers Disease

Keywords

Mild Cognitive Impairment (MCI); Alzheimers disease; Vitamines; Nutrients

Outcome Measures

Primary Outcomes (6)

• Vitamin A

  The concentration of Vitamin A = Retinol (1.4-3.4 mmol/l) will be measured in serum from patients and healthy controls, and compared.

  Up to 4 weeks after inclusion

• Vitamin B1

  The concentration of Vitamin B1 = Thiamin diphosphate (55 - 126 nmol/l) will be measured in blood from patients and healthy controls, and compared.

  Up to 4 weeks after inclusion

• Vitamin B6

  The concentration of Vitamin B6 = Pyridoxal-5 phosphate will be measured in serum from patients and healthy controls and compared.

  Up to 4 weeks after inclusion

• Vitamin B12

  The concentration of Vitamin B12 = Cobalamin (140-600 pmol/l) will be measured in serum from patients and healthy controls, and compared.

  Up to 4 weeks after inclusion

• Vitamin C

  The consentration of Vitamin C - Ascorbic acid (45-92 mmol/l) will be measured in serum of patients and healthy controls, and compared.

  Up to 4 weeks after inclusion

• Vitamin E

  The concentration of Vitamin E = Alfa-tocopherol (16 - 36 mmol/l)will be measured in serum from patients and healthy controls, and compared.

  Up to 4 weeks after inclusion

Secondary Outcomes (1)

• Cognitive function

  The cognitive testing will be performed between 0 to 4 weeks before the blood samples and spinal fluid is collected.

Study Arms (1)

Patients

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred consequtively to the Memory Clinic, Oslo University Hospital, Ullevål

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• South Eastern Area Health Service: collaborator

Study Sites (1)

OsloUH, Ullevål

Oslo, 0424, Norway

RECRUITING

Related Publications (4)

• Glaso M, Nordbo G, Diep L, Bohmer T. Reduced concentrations of several vitamins in normal weight patients with late-onset dementia of the Alzheimer type without vascular disease. J Nutr Health Aging. 2004;8(5):407-13.

  PMID: 15359361 BACKGROUND

• Aebersold R, Mann M. Mass spectrometry-based proteomics. Nature. 2003 Mar 13;422(6928):198-207. doi: 10.1038/nature01511.

  PMID: 12634793 BACKGROUND

• Nicholson JK, Lindon JC. Systems biology: Metabonomics. Nature. 2008 Oct 23;455(7216):1054-6. doi: 10.1038/4551054a. No abstract available.

  PMID: 18948945 BACKGROUND

• Mercier P, Lewis MJ, Chang D, Baker D, Wishart DS. Towards automatic metabolomic profiling of high-resolution one-dimensional proton NMR spectra. J Biomol NMR. 2011 Apr;49(3-4):307-23. doi: 10.1007/s10858-011-9480-x. Epub 2011 Mar 1.

  PMID: 21360156 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, urine, cerebrospinal fluid

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Ingun D Ulstein, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingun D Ulstein, MD PhD

CONTACT

95700025; ingun.ulstein@aldringoghelse.no

Thomas Bøhmer, MD PhD

CONTACT

t.bohmer@medisin.uio.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2011
• First Posted: November 28, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

NO (1)