Alzheimer's DiseaseNCT00105612
Memory Aid for Informed Consent in Alzheimer's Research
A study testing Memory and Organizational Aid and Standard Informed Consent Process in people with Alzheimer's Disease and Aging, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this trial is to test whether a memory and organizational aid in the form of a document that summarizes and simplifies a study's key points can improve the decision-making abilities and competency of mild to early moderate Alzheimer's disease (AD) patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease, Aging
- What is being tested?
- Memory and Organizational Aid and Standard Informed Consent Process
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Live within one hour drive of the University of Pennsylvania's Memory Disorders Clinic
- Education equivalent to 6th grade level
- Corrected visual acuity of at least 20/70
- Speak English
- Diagnosed with possible or probable AD, or non-demented
- MMSE (Mini Mental State Exam) >= 18
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Memory Disorders Clinic
Philadelphia, Pennsylvania, 19104
About this study
Official title: Improving Informed Consent in Alzheimer's Disease Research
The purpose of this trial is to test whether a memory and organizational aid in the form of a document that summarizes and simplifies a study's key points can improve the decision-making abilities and competency of mild to early moderate Alzheimer's disease (AD) patients.
Read the detailed description
Studies of mild to moderate Alzheimer's disease (AD) patients reveal substantial variation in their ability to participate in an informed consent process. No published data show techniques that help an AD patient to participate in an informed consent. This research will address this issue by performing a randomized trial to test whether a memory and organizational aid can improve the decision-making abilities and competency of AD patients.
This study will recruit 80 patients with mild to early moderate AD, and 30 non-demented elderly persons. The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home. The AD patients will be randomized to receive either the standard informed consent process or the intervention of the standard informed consent process plus the memory and organizational aid. All non-demented elderly individuals will receive the standard informed consent process. The interviewer will administer the protocol to participants and ask questions that will assess participant capacity to understand, appreciate, reason, and make a choice concerning enrollment in the hypothetical study.
- Conditions
- Alzheimer's Disease, Aging
- Being tested
- Memory and Organizational Aid, Standard Informed Consent Process
- Keywords
- Informed Consent, Memory Aid
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory and Organizational AidDevice
Standard Informed Consent ProcessBehavioural
The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home
What is being measured
The primary outcome is the main question the study is designed to answer.
MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities
Secondary outcomes (1)
Participant competency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2005 (estimated)
- Study startSep 2004
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Enrolment
- 110 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jason Karlawish, MD, Principal investigator, University of Pennsylvania Institute on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105612
- Sponsor's protocol ID
- IA0070
- Other IDs
- 1R01AG020627-01A2
- Status last verified
- Dec 2009
- First submitted
- 15 Mar 2005
- Last updated
- 29 Dec 2009
- Results posted
- No
Publications
Marson DC, Ingram KK, Cody HA, Harrell LE. Assessing the competency of patients with Alzheimer's disease under different legal standards. A prototype instrument. Arch Neurol. 1995 Oct;52(10):949-54. doi: 10.1001/archneur.1995.00540340029010.
PubMed 7575221Kim 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. doi: 10.1176/appi.ajp.158.5.712.
PubMed 11329391Sachs GA, Stocking CB, Stern R, Cox DM, Hougham G, Sachs RS. Ethical aspects of dementia research: informed consent and proxy consent. Clin Res. 1994 Oct;42(3):403-12. No abstract available.
PubMed 7955902Karlawish JH, Casarett DJ, James BD. Alzheimer's disease patients' and caregivers' capacity, competency, and reasons to enroll in an early-phase Alzheimer's disease clinical trial. J Am Geriatr Soc. 2002 Dec;50(12):2019-24. doi: 10.1046/j.1532-5415.2002.50615.x.
PubMed 12473015Appelbaum PS, Grisso T. The MacArthur Competence Assessment Tool - Clinical Research. Sarasota, FL: Professional Resources Press, 2000.
Rubright J, Sankar P, Casarett DJ, Gur R, Xie SX, Karlawish J. A memory and organizational aid improves Alzheimer disease research consent capacity: results of a randomized, controlled trial. Am J Geriatr Psychiatry. 2010 Dec;18(12):1124-32. doi: 10.1097/JGP.0b013e3181dd1c3b.
PubMed 20808101
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Informed Consent in Alzheimer's Disease Research
- ClinicalTrials.gov ID
- NCT00105612
- Acronym / sponsor ID
- IA0070
- Conditions
- Alzheimer's Disease, Aging
- Keywords
- Informed Consent, Memory Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Sep 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 16 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to test whether a memory and organizational aid in the form of a document that summarizes and simplifies a study's key points can improve the decision-making abilities and competency of mild to early moderate Alzheimer's disease (AD) patients.
Detailed description
Studies of mild to moderate Alzheimer's disease (AD) patients reveal substantial variation in their ability to participate in an informed consent process. No published data show techniques that help an AD patient to participate in an informed consent. This research will address this issue by performing a randomized trial to test whether a memory and organizational aid can improve the decision-making abilities and competency of AD patients.
This study will recruit 80 patients with mild to early moderate AD, and 30 non-demented elderly persons. The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home. The AD patients will be randomized to receive either the standard informed consent process or the intervention of the standard informed consent process plus the memory and organizational aid. All non-demented elderly individuals will receive the standard informed consent process. The interviewer will administer the protocol to participants and ask questions that will assess participant capacity to understand, appreciate, reason, and make a choice concerning enrollment in the hypothetical study.
Study design
- Allocation
- Randomised
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Live within one hour drive of the University of Pennsylvania's Memory Disorders Clinic
- Education equivalent to 6th grade level
- Corrected visual acuity of at least 20/70
- Speak English
- Diagnosed with possible or probable AD, or non-demented
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory and Organizational Aid | Device | – |
| Standard Informed Consent ProcessThe informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home | Behavioural | – |
Primary outcome
MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities
1 secondary outcome
Participant competency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2009.
- Background: PubMed 7575221Marson DC, Ingram KK, Cody HA, Harrell LE. Assessing the competency of patients with Alzheimer's disease under different legal standards. A prototype instrument. Arch Neurol. 1995 Oct;52(10):949-54. doi: 10.1001/archneur.1995.00540340029010.
- Background: PubMed 11329391Kim 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. doi: 10.1176/appi.ajp.158.5.712.
- Background: PubMed 7955902Sachs GA, Stocking CB, Stern R, Cox DM, Hougham G, Sachs RS. Ethical aspects of dementia research: informed consent and proxy consent. Clin Res. 1994 Oct;42(3):403-12. No abstract available.
- Background: PubMed 12473015Karlawish JH, Casarett DJ, James BD. Alzheimer's disease patients' and caregivers' capacity, competency, and reasons to enroll in an early-phase Alzheimer's disease clinical trial. J Am Geriatr Soc. 2002 Dec;50(12):2019-24. doi: 10.1046/j.1532-5415.2002.50615.x.
- BackgroundAppelbaum PS, Grisso T. The MacArthur Competence Assessment Tool - Clinical Research. Sarasota, FL: Professional Resources Press, 2000.
- Derived from this study: PubMed 20808101Rubright J, Sankar P, Casarett DJ, Gur R, Xie SX, Karlawish J. A memory and organizational aid improves Alzheimer disease research consent capacity: results of a randomized, controlled trial. Am J Geriatr Psychiatry. 2010 Dec;18(12):1124-32. doi: 10.1097/JGP.0b013e3181dd1c3b.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Karlawish, MD principal investigator
University of Pennsylvania Institute on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory and Organizational Aid and Standard Informed Consent Process in people with Alzheimer's Disease and Aging, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105612, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2009.