Alzheimer DiseaseBWP-ADNCT00453544

Enhancing Consent for Alzheimer's Research

A study testing Enhanced Consent Procedure and Routine Consent Procedure in people with Alzheimer Disease, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer Disease
What is being tested?: Enhanced Consent Procedure and Routine Consent Procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 252 participants
Where: 1 siteUnited States
Study dates: Apr 2006to Sep 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Veterans Affairs San Diego Healthcare System
San Diego, California, 92161

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Alzheimer Disease
Being tested: Enhanced Consent Procedure, Routine Consent Procedure
Keywords: computer assisted instruction, decision making, educational resource design /development, executive function
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhanced Consent ProcedureOther
This is a procedure involving use of multimedia materials, as well as standard review with research staff, to see if the research consent procedure can be improved
Routine Consent ProcedureOther
This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)

Study groups in NCT00453544
Study group	Role	What they receive
Enhanced consent - A	Experimental	The intervention was an enhanced consent process, including a multimedia aid for a moderate risk hypothetical protocol Receives: Other: Enhanced Consent Procedure
Enhanced consent - B	Experimental	The intervention was an enhanced consent process, including multimedia aide for a higher risk hypothetical protocol Receives: Other: Enhanced Consent Procedure
Routine consent - A	Active comparator	This was a comparison condition - a routine consent process, including a printed consent document, for a moderate risk hypothetical protocol Receives: Other: Routine Consent Procedure
Routine consent - B	Active comparator	This was a comparison condition - a routine consent process, including a printed consent document, for a higher risk hypothetical protocol Receives: Other: Routine Consent Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

Level of Understanding
Modified version of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Understanding subscale.
Minimum value = 0, Maximum value = 26; higher scores represent better performance
Measured: Within session - administered approximately 2-3 minutes after completion of the simulated consent process.
Appreciation
MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Appreciation subscale Minimum score = 0, Maximum Score = 6; Higher scores represent better understanding
Measured: Within session - immediately following administration of the MacCAT-CR Understanding subscale
Reasoning
Reasoning subscale of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Minimum score = 0; Maximum Score = 8; Higher scores mean better reasoning capacity
Measured: Within session-immediately following administration of the MacCAT-CR Appreciation subscale
Expression of a Choice
Expression of a Choice subscale of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR); Minimum score = 0, Maximum score = 2; higher scores represent more intact ability to express a clear choice
Measured: Within session--immediately following administration of the MacCAT-CR Reasoning subscale

Secondary outcomes (2)

Level of Satisfaction With Consent Process
Question - "The consent process was" rated from "Very easy" to "Very Hard"
1. Very Easy
2. Easy
3. No effect
4. Hard
5. Very hard Higher scores mean more difficult (less satisfaction) with the consent process
- with 1 being "Very Easy" and 5 being "Very hard"
Measured: Within session
Expressed Willingness to Participate in the Hypothetical Protocol
Question about willingness to consent in the protocol described 0 = No
1. = Yes
2. = Unsure
Measured: Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Sep 2012

First posted29 Mar 2007 (estimated)
Study startApr 2006
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Alzheimer 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
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00453544
Sponsor's protocol ID: IA0110
Other IDs: 1R01AG028827
Acronym: BWP-AD
Status last verified: Jun 2023
First submitted: 28 Mar 2007
Last updated: 6 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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. doi: 10.1176/appi.ajp.158.5.712.
PubMed 11329391
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. doi: 10.1097/01.wad.0000137520.23370.56.
PubMed 15494623
Kolata G. Alzheimer's research poses dilemma. Science. 1982 Jan 1;215(4528):47-8. doi: 10.1126/science.7053558.
PubMed 7053558
Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology. 2001 Jun;24(6):595-607. doi: 10.1016/S0893-133X(00)00218-9.
PubMed 11331139
Palmer BW, Harmell AL, Pinto LL, Dunn LB, Kim SY, Golshan S, Jeste DV. Determinants of Capacity to Consent to Research on Alzheimer's disease. Clin Gerontol. 2017;40(1):24-34. doi: 10.1080/07317115.2016.1197352. Epub 2016 Jun 7.
PubMed 28154452
Palmer BW, Harmell AL, Dunn LB, Kim SY, Pinto LL, Golshan S, Jeste DV. Multimedia Aided Consent for Alzheimer's Disease Research. Clin Gerontol. 2018 Jan-Feb;41(1):20-32. doi: 10.1080/07317115.2017.1373177. Epub 2017 Nov 28.
PubMed 29182458

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alzheimer Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancing Consent for Alzheimer's Research
ClinicalTrials.gov ID: NCT00453544
Acronym / sponsor ID: BWP-AD / IA0110
Conditions: Alzheimer Disease
Keywords: computer assisted instruction, decision making, educational resource design /development, executive function
Study type: Interventional
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Apr 2006
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 29 Mar 2007 (estimated)
Results: Posted 6 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Enhanced consent - A	Experimental	Other: Enhanced Consent ProcedureThe intervention was an enhanced consent process, including a multimedia aid for a moderate risk hypothetical protocol
Enhanced consent - B	Experimental	Other: Enhanced Consent ProcedureThe intervention was an enhanced consent process, including multimedia aide for a higher risk hypothetical protocol
Routine consent - A	Active comparator	Other: Routine Consent ProcedureThis was a comparison condition - a routine consent process, including a printed consent document, for a moderate risk hypothetical protocol
Routine consent - B	Active comparator	Other: Routine Consent ProcedureThis was a comparison condition - a routine consent process, including a printed consent document, for a higher risk hypothetical protocol

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (4 listed)

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

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
Enhanced Consent ProcedureThis is a procedure involving use of multimedia materials, as well as standard review with research staff, to see if the research consent procedure can be improved	Other	Enhanced consent - A, Enhanced consent - B
Routine Consent ProcedureThis is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)	Other	Routine consent - A, Routine consent - B

Primary outcome

Level of Understanding
Time frame: Within session - administered approximately 2-3 minutes after completion of the simulated consent process.
Modified version of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Understanding subscale. Minimum value = 0, Maximum value = 26; higher scores represent better performance
Appreciation
Time frame: Within session - immediately following administration of the MacCAT-CR Understanding subscale
MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Appreciation subscale Minimum score = 0, Maximum Score = 6; Higher scores represent better understanding
Reasoning
Time frame: Within session-immediately following administration of the MacCAT-CR Appreciation subscale
Reasoning subscale of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Minimum score = 0; Maximum Score = 8; Higher scores mean better reasoning capacity
Expression of a Choice
Time frame: Within session--immediately following administration of the MacCAT-CR Reasoning subscale
Expression of a Choice subscale of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR); Minimum score = 0, Maximum score = 2; higher scores represent more intact ability to express a clear choice

2 secondary outcomes

Level of Satisfaction With Consent Process
Time frame: Within session
Expressed Willingness to Participate in the Hypothetical Protocol
Time frame: Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale

Results and safety

Results posted to the registry on 6 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enhanced Consent - A	62	60
Enhanced Consent - B	55	54
Routine Consent - A	68	68
Routine Consent - B	67	66

Primary outcome: Level of Understanding

Time frame: Within session - administered approximately 2-3 minutes after completion of the simulated consent process.. Mean (Standard Deviation). Unit: score on a scale (MacCAT-CR Und Trial 2)

Measure	AD Enhanced Consent - Mod Risk n = 26	AD Enhanced Consent - Higher Risk n = 24	AD Routine Consent - Mod Risk n = 33	AD Routine Consent - Higher Risk n = 31	NC Enhanced Consent - Mod Risk n = 34	NC Enhanced Consent - Higher Risk n = 30	NC Routine Consent - Mod Risk n = 35	NC Routine Consent - Higher Risk n = 35
Value	17.8 (7.0)	16.8 (7.6)	15.1 (6.9)	15.7 (7.7)	25.2 (1.1)	24.8 (2.2)	25.3 (1.1)	24.9 (2.3)

Population analysed: 114 people with Alzheimer's disease (AD); 134 non-neuropsychiatric comparison (NC) subjects; the effects of routine vs. enhanced consent and moderate vs. higher risk were analyzed within diagnostic groups separately

Primary outcome: Appreciation

Time frame: Within session - immediately following administration of the MacCAT-CR Understanding subscale. Mean (Standard Deviation). Unit: score on a scale

Measure	AD Enhanced Consent - Mod Risk n = 26	AD Enhanced Consent - Higher Risk n = 24	AD Routine Consent - Mod Risk n = 33	AD Routine Consent - Higher Risk n = 31	NC Enhanced Consent - Mod Risk n = 33	NC Enhanced Consent - Higher Risk n = 30	NC Routine Consent - Mod Risk n = 35	NC Routine Consent - Higher Risk n = 34
Value	4.2 (1.8)	4.2 (1.6)	4.2 (1.3)	4.1 (1.7)	5.5 (0.8)	4.7 (1.1)	5.2 (1.0)	5.1 (1.1)

Population analysed: 114 people with Alzheimer's disease (AD); 132 non-neuropsychiatric comparison (NC) subjects; the effects of routine vs. enhanced consent and moderate vs. higher risk were analyzed within diagnostic groups separately

Primary outcome: Reasoning

Time frame: Within session-immediately following administration of the MacCAT-CR Appreciation subscale. Mean (Standard Deviation). Unit: score on a scale

Measure	AD Enhanced Consent - Mod Risk n = 26	AD Enhanced Consent - Higher Risk n = 23	AD Routine Consent - Mod Risk n = 33	AD Routine Consent - Higher Risk n = 30	NC Enhanced Consent - Mod Risk n = 34	NC Enhanced Consent - Higher Risk n = 30	NC Routine Consent - Mod Risk n = 35	NC Routine Consent - Higher Risk n = 34
Value	6.9 (1.5)	6.2 (2.5)	5.6 (2.5)	6.3 (2.4)	7.6 (0.7)	7.5 (0.8)	7.3 (1.3)	7.5 (0.9)

Population analysed: 112 people with Alzheimer's disease (AD); 133 non-neuropsychiatric comparison (NC) subjects; the effects of routine vs. enhanced consent and moderate vs. higher risk were analyzed within diagnostic groups separately

Primary outcome: Expression of a Choice

Time frame: Within session--immediately following administration of the MacCAT-CR Reasoning subscale. Mean (Standard Deviation). Unit: units on a scale

Measure	AD Enhanced Consent - Mod Risk n = 26	AD Enhanced Consent - Higher Risk n = 23	AD Routine Consent - Mod Risk n = 33	AD Routine Consent - Higher Risk n = 30	NC Enhanced Consent - Mod Risk n = 34	NC Enhanced Consent - Higher Risk n = 30	NC Routine Consent - Mod Risk n = 35	NC Routine Consent - Higher Risk n = 34
Value	1.8 (0.6)	1.7 (0.7)	1.7 (0.6)	1.5 (0.8)	1.9 (0.2)	2.0 (0.0)	1.9 (0.2)	1.9 (0.3)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were not monitored/assessed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Enhanced Consent - A	0 of 0	0 of 0
Enhanced Consent - B	0 of 0	0 of 0
Routine Consent - A	0 of 0	0 of 0
Routine Consent - B	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 15494623Alzheimer'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. doi: 10.1097/01.wad.0000137520.23370.56.
Background: PubMed 7053558Kolata G. Alzheimer's research poses dilemma. Science. 1982 Jan 1;215(4528):47-8. doi: 10.1126/science.7053558.
Background: PubMed 11331139Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology. 2001 Jun;24(6):595-607. doi: 10.1016/S0893-133X(00)00218-9.
Results publication: PubMed 28154452Palmer BW, Harmell AL, Pinto LL, Dunn LB, Kim SY, Golshan S, Jeste DV. Determinants of Capacity to Consent to Research on Alzheimer's disease. Clin Gerontol. 2017;40(1):24-34. doi: 10.1080/07317115.2016.1197352. Epub 2016 Jun 7.
Results publication: PubMed 29182458Palmer BW, Harmell AL, Dunn LB, Kim SY, Pinto LL, Golshan S, Jeste DV. Multimedia Aided Consent for Alzheimer's Disease Research. Clin Gerontol. 2018 Jan-Feb;41(1):20-32. doi: 10.1080/07317115.2017.1373177. Epub 2017 Nov 28.

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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.

Barton W. Palmer, PhD principal investigator

UCSD

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Consent Procedure and Routine Consent Procedure in people with Alzheimer Disease, run by University of California, San Diego 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 4 inclusion and 4 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 6 Jun 2023. 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?

Yes. Results are posted in the registry (first posted 6 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Level of Understanding (time frame: Within session - administered approximately 2-3 minutes after completion of the simulated consent process.). The study lists 4 primary outcomes in all. 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 NCT00453544, 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 6 Jun 2023; AzTrials last refreshed its copy on 31 Oct 2026.