N/A
N=252
Enhancing Consent for Alzheimer's Research
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT00453544 ↗Enrolled (actual)
252
Serious AEs
—
Results posted
Jun 2023
Primary outcome: Primary: Level of Understanding — 17.8; 16.8; 15.1; 15.7 score on a scale (MacCAT-CR Und Trial 2)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced Consent Procedure (Other); Routine Consent Procedure (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Level of Understanding |
17.8; 16.8; 15.1; 15.7; 25.2; 24.8 | — |
| PRIMARY Appreciation |
4.2; 4.2; 4.2; 4.1; 5.5; 4.7 | — |
| PRIMARY Reasoning |
6.9; 6.2; 5.6; 6.3; 7.6; 7.5 | — |
| PRIMARY Expression of a Choice |
1.8; 1.7; 1.7; 1.5; 1.9; 2.0 | — |
| SECONDARY Level of Satisfaction With Consent Process |
1.3; 2.4; 2.0; 1.9; 1.9; 1.8 | — |
| SECONDARY Expressed Willingness to Participate in the Hypothetical Protocol |
76; 83; 81; 71; 79; 67 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of mild to moderate possible or probable AD or demographically comparable healthy comparison subjects
- Fluency in English
- 50 yrs and older
- Informed written consent (or written assent with consent from legally authorized representative)
Exclusion Criteria
- Diagnosis of Lewy Body Dementia or Mild Cognitive Impairment
- MMSE less than 15
- Physical or medical conditions that preclude participants from completing tasks
- Healthy comparison volunteers if they have a known neurologic or psychiatric condition that could impair neurocognitive functioning
Data sourced from ClinicalTrials.gov (NCT00453544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.