Alzheimer DiseaseNCT05672732
Assessment of Clinical Trial Experiences of Alzheimer's Disease Patients
An observational study of Alzheimer Disease, run by Power Life Sciences Inc..
Trial summary
Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2026
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Alzheimer's Disease patients who are actively considering involvement in an interventional clinical trial, but have not yet completed enrollment and registration.
Who may be able to join
- Patient is at least 50 to 80 years of age
- Participant has a diagnosis of Alzheimer's Disease
- Patient has self-identified as planning to enroll in an interventional clinical trial for Alzheimer's Disease
Who cannot join
- No diagnosis of Alzheimer's Disease confirmed
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
Trial locations and contacts
No sites are listed yet.
About this study
Official title: In Depth Observational Clinical Trial Assessing Experiences of Alzheimer's Disease Patients To Determine Trial Attributes Affecting Completion Rates For Specific Demographic Groups
Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This study will admit a wide range of data on the clinical trial experience of Alzheimer's Disease patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Alzheimer's Disease patients.
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, Alzheimer's
- Medical subject headings
- Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in a Alzheimer's Disease Clinical Trial
Measured: 3 months
Number of patients who remain in Alzheimer's Disease clinical trial until completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672732
- Sponsor's protocol ID
- 81466128
- Status last verified
- Jun 2023
- First submitted
- 3 Jan 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eratne D, Loi SM, Farrand S, Kelso W, Velakoulis D, Looi JC. Alzheimer's disease: clinical update on epidemiology, pathophysiology and diagnosis. Australas Psychiatry. 2018 Aug;26(4):347-357. doi: 10.1177/1039856218762308. Epub 2018 Apr 3.
PubMed 29614878Mangialasche F, Solomon A, Winblad B, Mecocci P, Kivipelto M. Alzheimer's disease: clinical trials and drug development. Lancet Neurol. 2010 Jul;9(7):702-16. doi: 10.1016/S1474-4422(10)70119-8.
PubMed 20610346Rafii MS, Aisen PS. Alzheimer's Disease Clinical Trials: Moving Toward Successful Prevention. CNS Drugs. 2019 Feb;33(2):99-106. doi: 10.1007/s40263-018-0598-1.
PubMed 30560544
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Depth Observational Clinical Trial Assessing Experiences of Alzheimer's Disease Patients To Determine Trial Attributes Affecting Completion Rates For Specific Demographic Groups
- ClinicalTrials.gov ID
- NCT05672732
- Acronym / sponsor ID
- 81466128
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, Alzheimer's
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 5 Jan 2023 (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.
Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This study will admit a wide range of data on the clinical trial experience of Alzheimer's Disease patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Alzheimer's Disease patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Alzheimer's Disease patients who are actively considering involvement in an interventional clinical trial, but have not yet completed enrollment and registration.
Key inclusion criteria (3 listed)
- Patient is at least 50 to 80 years of age
- Participant has a diagnosis of Alzheimer's Disease
- Patient has self-identified as planning to enroll in an interventional clinical trial for Alzheimer's Disease
Key exclusion criteria (3 listed)
- No diagnosis of Alzheimer's Disease confirmed
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of patients who decide to enroll in a Alzheimer's Disease Clinical Trial
Time frame: 3 months
Number of patients who remain in Alzheimer's Disease clinical trial until completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 29614878Eratne D, Loi SM, Farrand S, Kelso W, Velakoulis D, Looi JC. Alzheimer's disease: clinical update on epidemiology, pathophysiology and diagnosis. Australas Psychiatry. 2018 Aug;26(4):347-357. doi: 10.1177/1039856218762308. Epub 2018 Apr 3.
- Background: PubMed 20610346Mangialasche F, Solomon A, Winblad B, Mecocci P, Kivipelto M. Alzheimer's disease: clinical trials and drug development. Lancet Neurol. 2010 Jul;9(7):702-16. doi: 10.1016/S1474-4422(10)70119-8.
- Background: PubMed 30560544Rafii MS, Aisen PS. Alzheimer's Disease Clinical Trials: Moving Toward Successful Prevention. CNS Drugs. 2019 Feb;33(2):99-106. doi: 10.1007/s40263-018-0598-1.
- Individual participant dataSharing planned: Undecided
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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.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Power Life Sciences Inc..
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (415-900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who decide to enroll in a Alzheimer's Disease Clinical Trial (time frame: 3 months). The study lists 2 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 NCT05672732, which also lists 3 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 18 Jun 2023.