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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. Identifier: NCT01554475
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : February 18, 2015
Kløveråsen Center for dementia, Bodø
Information provided by (Responsible Party):
University Hospital of North Norway

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.

Condition or disease
Dementia Cognitive Impairment

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.

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Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Alternative Medicine Among Patients With Dementia and Mild Cognitive Dysfunction
Study Start Date : March 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients diagnosed with dementia, under follow-up at Kløveråsen out-patient clinic

Inclusion Criteria:

  • diagnosed with dementia

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 identifier (NCT number): NCT01554475

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Bodø, Norway, N-8076
Sponsors and Collaborators
University Hospital of North Norway
Kløveråsen Center for dementia, Bodø
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Study Chair: Trude Giverhaug, PhD University Hospital North-Norway

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Responsible Party: University Hospital of North Norway Identifier: NCT01554475    
Other Study ID Numbers: 2011/1705(REK)
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015
Keywords provided by University Hospital of North Norway:
herbal drugs
dietary supplements
drug interactions
Additional relevant MeSH terms:
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Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders