Clinical Trials

Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old

Description

Status: Closed to Enrollment

Start Date: Jan 09 2008

End Date: OPEN

Objective:

Establish the feasibility of the three in-house assessments methods—Mail in forms with live phone, automated telephone IVR technology and computer-based kiosk assessment and validate them by comparing them to traditional evaluation instruments. To evaluate the ability of the brief instruments proposed here to capture rate of change as an outcome for primary prevention trials. To examine medication adherence as a performance based assessment of functional ability in all 3 methods.

Inclusion Criteria:

  1. Age 75 and older
  2. Willingness to sign consent
  3. Willingness to take multi-vitamins provided by the study
  4. Minimal computer skills or willingness to learn (as demonstrated by completion during screening of a demonstration module for each arm)
  5. English fluency
  6. MMSE >26
  7. Able to answer and dial a telephone
  8. Ability to complete the in-person assessment
  9. Ability to complete the computerized assessment including adequate speech, hearing and vision
  10. Independently living adults, defined as living in a setting in which the participant can ensure access to the resources for study procedures. For example, sites should ensure that a study phone and a computer kiosk with fast internet access can be installed and that the participant has access to postal mail.
  11. Participation of a study partner is desirable and encouraged but not required

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

  1. Dementia
  2. Use of prescriptive cognitive-enhancing drugs at entry
  3. Intent to continue use of own multi-vitamins (for the duration of the study participants Must agree to take only study-distributed multi-vitamins. Additional supplements will not be monitored.)
  4. History or presence of major psychiatric, neurological or neurodegenerative conditions associated with significant cognitive impairment such as major stroke, Parkinson’s disease, Multiple Sclerosis or Huntington’s disease. (TIA is acceptable if > 6 months ago)
  5. Medical conditions associated with life expectancy of less than 5 years
  6. Transient domicile interfering with ability to collect study-related data
  7. Current participation in a clinical trial involving CNS medications or cognitive testing that would interfere with the current protocol (participation in UDS assessments by an ADC is permitted).
  8. Cohabitation with another participant in this particular study.

Principal Investigators

Richard King, M.D.

Contact Information

Name: Richard King, MD, PhD
Phone: (801) 587-7888
Email:

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