The purpose of this study is to evaluate the efficacy of an enhanced consent procedure for patients with mild to moderate Alzheimer disease and to identify factors and patient characteristics that predict the degree to which enhanced consent is more beneficial than routine consent procedures.
Accepts Healthy Volunteers
++Clinical diagnosis of mild to moderate possible or probable AD or comparable healthy comparison subjects++Fluency in English++50 years and older++Informed written consent (or written assent with consent from legally authorized representative)
++Diagnosis of Lewy body dementia or mild cognitive impairment++Mini Mental State Exam score of less than 15++Physical or medical conditions that preclude participants from completing tasks++Neurologic or psychiatric condition that could impair neurocognitive functioning in healthy volunteers
Alzheimer disease can impair the capacity of patients to give informed consent for research participation. Studies of informed consent involving other patient populations suggest better understanding of consent-relevant information may be achieved through modifications in the consent delivery process, including incorporation of multimedia learning tools into the consent discussion.
In the present study, participants with Alzheimer disease and age-comparable healthy participants will be randomly assigned to review a hypothetical research protocol via routine or enhanced consent procedures. Participants will also complete standard cognitive and other rating scales so that we can characterize the sample, as well as evaluate the degree to which specific characteristics may be associated with need for enhanced consent procedures. Advances in the methods to optimize the informed consent process should enable future research participants to make more fully informed decisions.
http://www.ncbi.nlm.nih.gov/pubmed/11329391">Kim SY, Caine ED, Currier GW, Leibovici A, Ryan JM. Assessing the competence of persons with Alzheimer`s disease in providing informed consent for participation in research. Am J Psychiatry. 2001 May;158(5):712-7. http://www.ncbi.nlm.nih.gov/pubmed/15494623">Alzheimer`s Association. Research consent for cognitively impaired adults: recommendations for institutional review boards and investigators. Alzheimer Dis Assoc Disord. 2004 Jul-Sep;18(3):171-5. http://www.ncbi.nlm.nih.gov/pubmed/7053558">Kolata G. Alzheimer`s research poses dilemma. Science. 1982 Jan 1;215(4528):47-8. http://www.ncbi.nlm.nih.gov/pubmed/11331139">Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology. 2001 Jun;24(6):595-607.