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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01554475
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : February 18, 2015
Sponsor:
Collaborator:
Kløveråsen Center for dementia, Bodø
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date January 13, 2012
First Posted Date March 15, 2012
Last Update Posted Date February 18, 2015
Study Start Date March 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2012)
Number of patients taking alternative medicines [ Time Frame: Up to 2 years ]
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 12, 2012)
  • Numbers of potential and clinical relevant interactions [ Time Frame: Up to 2 years ]
    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 ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Use of Alternative Medicine in Patients With Dementia and Mild Cognitive Dysfunction
Official Title Use of Alternative Medicine Among Patients With Dementia and Mild Cognitive Dysfunction
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients diagnosed with dementia, under follow-up at Kløveråsen out-patient clinic
Condition
  • Dementia
  • Cognitive Impairment
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 16, 2015)
151
Original Estimated Enrollment
 (submitted: March 12, 2012)
150
Actual Study Completion Date October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • diagnosed with dementia
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01554475
Other Study ID Numbers 2011/1705(REK)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital of North Norway
Study Sponsor University Hospital of North Norway
Collaborators Kløveråsen Center for dementia, Bodø
Investigators
Study Chair: Trude Giverhaug, PhD University Hospital North-Norway
PRS Account University Hospital of North Norway
Verification Date February 2015