DementiaNCT05850000
Discovering Factors in the Clinical Trial Journey of Dementia Patients
An observational study of Dementia, run by Power Life Sciences Inc..
Trial summary
This research aims to collect comprehensive data on the clinical trial experience of dementia patients. Its goal is to identify the factors that limit patients' ability to join or complete a trial successfully. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Dementia
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with dementia who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.
Who may be able to join
- Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
- Participant has a diagnosis of dementia.
- Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
Who cannot join
- Pregnant or lactating woman
- Enrolled in another research study
- Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Dementia Clinical Trials: A Study on the Clinical Trial Participation of Dementia Patients
This research aims to collect comprehensive data on the clinical trial experience of dementia patients. Its goal is to identify the factors that limit patients' ability to join or complete a trial successfully. Clinical trial participation often favors specific demographic groups, and limited research exists on the impact of trial attributes on participation. Therefore, this study aims to analyze data from various demographic groups and identify any recurring trends that could provide valuable insights for future dementia patients.
- Conditions
- Dementia
- Keywords
- dementia
- Medical subject headings
- Dementia
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 dementia clinical study.
Measured: 3 months
Number of dementia patients who remain in 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 posted9 May 2023
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 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 DementiaStudies 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
- NCT05850000
- Sponsor's protocol ID
- 94341447
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Perng CH, Chang YC, Tzang RF. The treatment of cognitive dysfunction in dementia: a multiple treatments meta-analysis. Psychopharmacology (Berl). 2018 May;235(5):1571-1580. doi: 10.1007/s00213-018-4867-y. Epub 2018 Mar 3.
PubMed 29502274Whitehouse PJ, Kittner B, Roessner M, Rossor M, Sano M, Thal L, Winblad B. Clinical trial designs for demonstrating disease-course-altering effects in dementia. Alzheimer Dis Assoc Disord. 1998 Dec;12(4):281-94. doi: 10.1097/00002093-199812000-00007.
PubMed 9876956Graham NS, Sharp DJ. Understanding neurodegeneration after traumatic brain injury: from mechanisms to clinical trials in dementia. J Neurol Neurosurg Psychiatry. 2019 Nov;90(11):1221-1233. doi: 10.1136/jnnp-2017-317557. Epub 2019 Sep 21.
PubMed 31542723
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia Clinical Trials: A Study on the Clinical Trial Participation of Dementia Patients
- ClinicalTrials.gov ID
- NCT05850000
- Acronym / sponsor ID
- 94341447
- Conditions
- Dementia
- Keywords
- dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 9 May 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.
This research aims to collect comprehensive data on the clinical trial experience of dementia patients. Its goal is to identify the factors that limit patients' ability to join or complete a trial successfully. Clinical trial participation often favors specific demographic groups, and limited research exists on the impact of trial attributes on participation. Therefore, this study aims to analyze data from various demographic groups and identify any recurring trends that could provide valuable insights for future dementia patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dementia who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.
Key inclusion criteria (3 listed)
- Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
- Participant has a diagnosis of dementia.
- Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
Key exclusion criteria (3 listed)
- Pregnant or lactating woman
- Enrolled in another research study
- Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
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 dementia clinical study.
Time frame: 3 months
Number of dementia patients who remain in 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 9 May 2023.
- Background: PubMed 29502274Perng CH, Chang YC, Tzang RF. The treatment of cognitive dysfunction in dementia: a multiple treatments meta-analysis. Psychopharmacology (Berl). 2018 May;235(5):1571-1580. doi: 10.1007/s00213-018-4867-y. Epub 2018 Mar 3.
- Background: PubMed 9876956Whitehouse PJ, Kittner B, Roessner M, Rossor M, Sano M, Thal L, Winblad B. Clinical trial designs for demonstrating disease-course-altering effects in dementia. Alzheimer Dis Assoc Disord. 1998 Dec;12(4):281-94. doi: 10.1097/00002093-199812000-00007.
- Background: PubMed 31542723Graham NS, Sharp DJ. Understanding neurodegeneration after traumatic brain injury: from mechanisms to clinical trials in dementia. J Neurol Neurosurg Psychiatry. 2019 Nov;90(11):1221-1233. doi: 10.1136/jnnp-2017-317557. Epub 2019 Sep 21.
- 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 Dementia, 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 9 May 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 dementia clinical study. (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 NCT05850000, 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 9 May 2023.