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Use of Alternative Medicine in Patients With Dementia and Mild Cognitive Dysfunction

This study is currently recruiting participants.
Verified May 2012 by University Hospital of North Norway
Sponsor:
Collaborator:
Kløveråsen Center for dementia, Bodø
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01554475
First received: January 13, 2012
Last updated: May 6, 2012
Last verified: May 2012
History of Changes
  Purpose

So far, no drugs have shown to stop or delay the pathological processes of dementia. Available pharmacological treatment includes a small number of drugs; cholinesterase inhibitors like donepezil, galantamine and rivastigmine, and the NMDA receptor antagonist memantine, all of which only affect the symptoms of the disease. At the same time, alternative medicines like herbal products and dietary supplements are often intensively marketed with the assertion of curative or alleviating effects on dementia. The documentation of clinical effects, side effects and the potential for interaction with prescribed drugs are, however, generally scarce. The aims of this study are to make a survey of the use of alternative medicine in patients with dementia and mild cognitive dysfunction attending the investigators out-patient dementia clinic, and to assess the interaction potential with the patient's other medications.


Condition
Dementia
Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Alternative Medicine Among Patients With Dementia and Mild Cognitive Dysfunction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Number of patients taking alternative medicines [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    The patient's use of alternative medicine(s) on a given point of time (the consultation date) as reported by the patient or by the next of kin who is the patient's companion during the consultation. The results will be presented as the number of patients taking alternative medicines


Secondary Outcome Measures:
  • Numbers of potential and clinical relevant interactions [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Assessment of the potential of interactions between the patient's alternative medicines and prescribed or over-the-counter drugs in use at the date of the consultation. The assessment will be based on data from litterature reports. Results will be presented as numbers of potential and clinical relevant interactions.

  • The patient's subjective experiences with alternative medicines [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    In the interview the patients will be asked to tell if they have experienced positive, negative, or no effects related to their use of alternative medicines. Results will be presented as number of patients.


Estimated Enrollment: 150
Study Start Date: March 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Patients: All patients with a diagnosis of dementia under follow-up at the out-patient clinic are invited to participate, if giving a written consent.

Method: a semi-structured interview is undertaken by the doctor at the end of the consultation. Patients and their company are asked to name their alternative medicines (if any), for how long the products have been used, where and how they learned about the products, ant to tell about their experiences with the products (i.e if they have noticed effects or side-effects). After the consultation information of the the actual product's contents and properties are obtained and an assessment of possible interactions with the patient's other drugs (prescriptions and self-reported use of over-the-counter drugs) is made. Reported effects or side-effects are registered.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients diagnosed with dementia, under follow-up at Kløveråsen out-patient clinic

Criteria

Inclusion Criteria:

  • diagnosed with dementia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554475

Contacts
Contact: Hilde Risvoll, MD +47 90095535 hilde.monica.risvoll@nordlandssykehuset.no

Locations
Norway
Kløveråsen Recruiting
Bodø, Norway, N-8076
Contact: Hilde Risvoll, MD     +47 90095535     hilde.monica.risvoll@nordlandssykehuset.no    
Principal Investigator: Hilde Risvoll, MD            
Sponsors and Collaborators
University Hospital of North Norway
Kløveråsen Center for dementia, Bodø
Investigators
Study Chair: Trude Giverhaug, PhD University Hospital North-Norway
  More Information

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01554475     History of Changes
Other Study ID Numbers: 2011/1705(REK)
Study First Received: January 13, 2012
Last Updated: May 6, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority

Keywords provided by University Hospital of North Norway:
herbal drugs
dietary supplements
drug interactions

Additional relevant MeSH terms:
Dementia
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013