Alzheimer DiseaseNCT05377060
Disclosing Dementia Risk Based on Plasma Phosphorylated Tau
A study testing Plasma p-tau risk disclosure and Standard risk disclosure in people with Alzheimer Disease and Mild Cognitive Impairment, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Novel blood-based biomarkers of Alzheimer's disease (AD), such as plasma levels of tau phosphorylated at threonine 181 (p-tau181), have shown great promise in detecting early AD pathology. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Plasma p-tau risk disclosure and Standard risk disclosure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 Jun 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants recruited will include 62 adults aged 60 and older.
- Consensus diagnosis of amnestic MCI by Vanderbilt Alzheimer's Disease Research Center (VADRC) clinician panel.
- Availability of a reliable study partner (reliable is defined as someone who interacts significantly with the participant and is available to participate in study visits in person).
- English language fluency.
Who cannot join
- Individuals who lack decisional capacity to provide informed consent at baseline will not be enrolled in the study.
- History of major psychiatric illness (e.g., schizophrenia, bipolar), neurological illness (e.g., epilepsy, multiple sclerosis, Parkinson's disease), or head injury with significant loss of consciousness.
- Presence of acute psychological distress (i.e., Geriatric Depression Scale >10 at screening).
- Participation in other risk disclosure protocols.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Illinois, 37212
About this study
Novel blood-based biomarkers of Alzheimer's disease (AD), such as plasma levels of tau phosphorylated at threonine 181 (p-tau181), have shown great promise in detecting early AD pathology. While current studies point to this biomarker as having great clinical utility, one necessary step before clinical implementation is developing safe and effective methods for disclosure of results. Past risk disclosure studies have shown that disclosing risk for AD based on genetics or amyloid status is safe, but these studies have largely focused on cognitively unimpaired individuals. This study seeks to develop comprehensible educational materials to aid risk disclosure and examine the effect of risk disclosure based on plasma p-tau181 results in a group of participants with mild cognitive impairment (MCI) at imminent risk of converting to dementia. First, educational materials will be developed in collaboration with health communication experts and then refined in focus groups made up of individuals with MCI. Educational materials will be analyzed on several key reading and comprehensibility metrics and will include personalized risk estimate based on a well-accepted risk algorithm (Cullen, et al., 2021). Next, these educational materials will be utilized to disclose risk in a randomized controlled trial with an active control arm receiving disclosure based on age, sex, and cognitive status (based on Mini-Mental State Examination), meant to mimic common methods of clinical diagnostic and prognostic decision making, and an intervention arm receiving disclosure based on the above factors plus plasma p-tau181 results. Outcomes will include measures of comprehension and psychological well-being (anxiety, depression, hopelessness, and distress) and will be assessed immediately after risk disclosure and again at six-month follow-up. It is hypothesized that risk disclosure based on plasma p-tau181 is not more psychologically harmful or less comprehensible than disclosure based on demographic factors and MMSE. This pilot study will provide a necessary step towards moving plasma p-tau biomarkers towards safe clinical implementation and will develop educational materials that can be utilized in future studies and clinical practice.
Read the detailed description
Novel blood-based biomarkers of Alzheimer's disease (AD), such as plasma levels of tau phosphorylated at threonine 181 (p-tau181), have shown great promise in sensitively and specifically detecting early AD pathology. Plasma p-tau181 has the potential to dramatically reduce the financial strain and patient care burden associated with identifying patients at increased risk of AD-dementia, as well as improve screening for enrollment in clinical trials which require the presence of AD-pathological changes. While current studies point to this biomarker as having great clinical utility, one necessary step before clinical implementation is developing safe and effective methods for disclosure of results. Past risk disclosure studies have shown that disclosing risk for AD based on genetics or amyloid status is safe, but these studies have largely focused on cognitively unimpaired individuals. This study seeks to develop comprehensible educational materials to aid risk disclosure and examine the effect of risk disclosure based on plasma p-tau181 results in a group of participants with mild cognitive impairment (MCI) at imminent risk of converting to dementia. First, educational materials will be developed in collaboration with health communication experts and then refined in focus groups made up of individuals with MCI. Educational materials will be analyzed on several key reading and comprehensibility metrics and will include personalized risk estimate based on a well-accepted risk algorithm (Cullen, et al., 2021). Next, these educational materials will be utilized to disclose risk in a randomized controlled trial with an active control arm receiving disclosure based on age, sex, and cognitive status (based on Mini-Mental State Examination), meant to mimic common methods of clinical diagnostic and prognostic decision making, and an intervention arm receiving disclosure based on the above factors plus plasma p-tau181 results. Outcomes will include measures of comprehension and psychological well-being (anxiety, depression, hopelessness, and distress) and will be assessed immediately after risk disclosure and again at six-month follow-up. It is hypothesized that risk disclosure based on plasma p-tau181 is not more psychologically harmful or less comprehensible than disclosure based on demographic factors and MMSE. This pilot study will provide a necessary step towards moving plasma p-tau biomarkers towards safe clinical implementation and will develop educational materials that can be utilized in future studies and clinical practice.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- Plasma p-tau risk disclosure, Standard risk disclosure
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma p-tau risk disclosureBehavioural
Participants will receive an estimated risk for converting to dementia in the next four years based on age, sex, MMSE score, and plasma p-tau results.
Standard risk disclosureBehavioural
Participants will receive an estimated risk for converting to dementia in the next four years based on age, sex, and MMSE score.
| Study group | Role | What they receive |
|---|---|---|
| Plasma p-tau Disclosure | Experimental | To receive risk estimate based on plasma p-tau results in addition to age, sex, and cognitive screening score. Receives: Behavioral: Plasma p-tau risk disclosure |
| Standard Disclosure | Active comparator | To receive risk estimate based on age, sex, and cognitive screening score. Receives: Behavioral: Standard risk disclosure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Depression Scale
Questionnaire assessing depression
Measured: Immediately following disclosure
Geriatric Depression Scale - 6-month follow-up
Questionnaire assessing depression
Measured: Immediately following disclosure and at 6-month follow-up
Geriatric Anxiety Scale
Questionnaire assessing anxiety
Measured: Immediately following disclosure
Geriatric Anxiety Scale - 6-month follow-up
Questionnaire assessing anxiety
Measured: At 6-month follow-up
Beck Hopelessness Scale
Questionnaire assessing hopelessness
Measured: Immediately following disclosure
Beck Hopelessness Scale - 6-month follow-up
Questionnaire assessing hopelessness
Measured: At 6-month follow-up
Impact of Events Scale
Questionnaire assessing event-related distress
Measured: At 6-month follow-up
Immediate Comprehension
Semi-structured interview to assess comprehension of disclosure information
Measured: Immediately following disclosure
Long-term Comprehension
Semi-structured interview to assess comprehension of disclosure information
Measured: At 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Sep 2022
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corey Bolton, Vanderbilt University Medical Center
- Investigators
- Corey J Bolton, PsyD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377060
- Sponsor's protocol ID
- 220449
- Status last verified
- Jun 2025
- First submitted
- 9 May 2022
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disclosing Dementia Risk Based on Plasma Phosphorylated Tau
- ClinicalTrials.gov ID
- NCT05377060
- Acronym / sponsor ID
- 220449
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 17 May 2022 (actual)
- 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.
Novel blood-based biomarkers of Alzheimer's disease (AD), such as plasma levels of tau phosphorylated at threonine 181 (p-tau181), have shown great promise in detecting early AD pathology. While current studies point to this biomarker as having great clinical utility, one necessary step before clinical implementation is developing safe and effective methods for disclosure of results. Past risk disclosure studies have shown that disclosing risk for AD based on genetics or amyloid status is safe, but these studies have largely focused on cognitively unimpaired individuals. This study seeks to develop comprehensible educational materials to aid risk disclosure and examine the effect of risk disclosure based on plasma p-tau181 results in a group of participants with mild cognitive impairment (MCI) at imminent risk of converting to dementia. First, educational materials will be developed in collaboration with health communication experts and then refined in focus groups made up of individuals with MCI. Educational materials will be analyzed on several key reading and comprehensibility metrics and will include personalized risk estimate based on a well-accepted risk algorithm (Cullen, et al., 2021). Next, these educational materials will be utilized to disclose risk in a randomized controlled trial with an active control arm receiving disclosure based on age, sex, and cognitive status (based on Mini-Mental State Examination), meant to mimic common methods of clinical diagnostic and prognostic decision making, and an intervention arm receiving disclosure based on the above factors plus plasma p-tau181 results. Outcomes will include measures of comprehension and psychological well-being (anxiety, depression, hopelessness, and distress) and will be assessed immediately after risk disclosure and again at six-month follow-up. It is hypothesized that risk disclosure based on plasma p-tau181 is not more psychologically harmful or less comprehensible than disclosure based on demographic factors and MMSE. This pilot study will provide a necessary step towards moving plasma p-tau biomarkers towards safe clinical implementation and will develop educational materials that can be utilized in future studies and clinical practice.
Detailed description
Novel blood-based biomarkers of Alzheimer's disease (AD), such as plasma levels of tau phosphorylated at threonine 181 (p-tau181), have shown great promise in sensitively and specifically detecting early AD pathology. Plasma p-tau181 has the potential to dramatically reduce the financial strain and patient care burden associated with identifying patients at increased risk of AD-dementia, as well as improve screening for enrollment in clinical trials which require the presence of AD-pathological changes. While current studies point to this biomarker as having great clinical utility, one necessary step before clinical implementation is developing safe and effective methods for disclosure of results. Past risk disclosure studies have shown that disclosing risk for AD based on genetics or amyloid status is safe, but these studies have largely focused on cognitively unimpaired individuals. This study seeks to develop comprehensible educational materials to aid risk disclosure and examine the effect of risk disclosure based on plasma p-tau181 results in a group of participants with mild cognitive impairment (MCI) at imminent risk of converting to dementia. First, educational materials will be developed in collaboration with health communication experts and then refined in focus groups made up of individuals with MCI. Educational materials will be analyzed on several key reading and comprehensibility metrics and will include personalized risk estimate based on a well-accepted risk algorithm (Cullen, et al., 2021). Next, these educational materials will be utilized to disclose risk in a randomized controlled trial with an active control arm receiving disclosure based on age, sex, and cognitive status (based on Mini-Mental State Examination), meant to mimic common methods of clinical diagnostic and prognostic decision making, and an intervention arm receiving disclosure based on the above factors plus plasma p-tau181 results. Outcomes will include measures of comprehension and psychological well-being (anxiety, depression, hopelessness, and distress) and will be assessed immediately after risk disclosure and again at six-month follow-up. It is hypothesized that risk disclosure based on plasma p-tau181 is not more psychologically harmful or less comprehensible than disclosure based on demographic factors and MMSE. This pilot study will provide a necessary step towards moving plasma p-tau biomarkers towards safe clinical implementation and will develop educational materials that can be utilized in future studies and clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma p-tau Disclosure | Experimental | Behavioral: Plasma p-tau risk disclosureTo receive risk estimate based on plasma p-tau results in addition to age, sex, and cognitive screening score. |
| Standard Disclosure | Active comparator | Behavioral: Standard risk disclosureTo receive risk estimate based on age, sex, and cognitive screening score. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants recruited will include 62 adults aged 60 and older.
- Consensus diagnosis of amnestic MCI by Vanderbilt Alzheimer's Disease Research Center (VADRC) clinician panel.
- Availability of a reliable study partner (reliable is defined as someone who interacts significantly with the participant and is available to participate in study visits in person).
- English language fluency.
Key exclusion criteria (4 listed)
- Individuals who lack decisional capacity to provide informed consent at baseline will not be enrolled in the study.
- History of major psychiatric illness (e.g., schizophrenia, bipolar), neurological illness (e.g., epilepsy, multiple sclerosis, Parkinson's disease), or head injury with significant loss of consciousness.
- Presence of acute psychological distress (i.e., Geriatric Depression Scale >10 at screening).
- Participation in other risk disclosure protocols.
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 |
|---|---|---|
| Plasma p-tau risk disclosureParticipants will receive an estimated risk for converting to dementia in the next four years based on age, sex, MMSE score, and plasma p-tau results. | Behavioural | Plasma p-tau Disclosure |
| Standard risk disclosureParticipants will receive an estimated risk for converting to dementia in the next four years based on age, sex, and MMSE score. | Behavioural | Standard Disclosure |
Primary outcome
Geriatric Depression Scale
Time frame: Immediately following disclosure
Questionnaire assessing depression
Geriatric Depression Scale - 6-month follow-up
Time frame: Immediately following disclosure and at 6-month follow-up
Questionnaire assessing depression
Geriatric Anxiety Scale
Time frame: Immediately following disclosure
Questionnaire assessing anxiety
Geriatric Anxiety Scale - 6-month follow-up
Time frame: At 6-month follow-up
Questionnaire assessing anxiety
Beck Hopelessness Scale
Time frame: Immediately following disclosure
Questionnaire assessing hopelessness
Beck Hopelessness Scale - 6-month follow-up
Time frame: At 6-month follow-up
Questionnaire assessing hopelessness
Impact of Events Scale
Time frame: At 6-month follow-up
Questionnaire assessing event-related distress
Immediate Comprehension
Time frame: Immediately following disclosure
Semi-structured interview to assess comprehension of disclosure information
Long-term Comprehension
Time frame: At 6-month follow-up
Semi-structured interview to assess comprehension of disclosure information
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 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Corey J Bolton, PsyD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma p-tau risk disclosure and Standard risk disclosure in people with Alzheimer Disease and Mild Cognitive Impairment, run by Vanderbilt University Medical Center 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 29 Jun 2025. 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?
Geriatric Depression Scale (time frame: Immediately following disclosure). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2025.