DementiaNCT05052450
Factors Associated With Mortality, Morbidity and Prognosis in Dementia Patients
An observational study of Dementia and Dementia, Vascular, run by Gulhane Training and Research Hospital.
Trial summary
Dementia; It is a chronic syndrome characterized by a general and progressive deterioration in cognition, including memory, orientation, language, and comprehension. The prognosis of this progressive and neurodegenerative disease after diagnosis may differ between individuals. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Dementia, Vascular, Dementia With Lewy Bodies
- What is being tested?
- Observational
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 31 Dec 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with any kind of dementia and being older than 60 years would be included in the study
Who may be able to join
- Having applied to the Gulhane Training and Research Hospital Geriatrics Polyclinic Being diagnosed with Alzheimer or Lewy Body Dementia or Vascular Dementia or Fronto-Temporal Dementia or Parkinson Disease Dementia Being at the age of 60 years or older
Who cannot join
- Being under the age of 60 Patients with insufficient recorded data and follow-up for the study Patients who either have diagnosis or follow-up in another center. Patients who have severe dementia that prevents applying for outpatient clinic
About this study
Dementia; It is a chronic syndrome characterized by a general and progressive deterioration in cognition, including memory, orientation, language, and comprehension. The prognosis of this progressive and neurodegenerative disease after diagnosis may differ between individuals. In its broadest sense, the prognosis after a diagnosis of dementia; can be defined by shortening of life span, high level of cognitive and functional loss, decrease in quality of life and increased need for care. However, the prognosis of different types of dementia is highly variable. Because it is the most common type of dementia, studies are usually on Alzheimer's disease. It constitutes 50-75% of total dementia cases. Vascular dementia is the second most common cause of dementia and accounts for approximately 15% of dementia cases. Dementia with Lewy bodies constitutes 10-20% of the total dementia patients and ranks second among degenerative dementia types. Frontotemporal dementia, which mimics psychiatric disorders and has prominent behavioural problems, and Parkinson's disease-associated dementia, which is characterized by cognitive impairment that can be added to the existing picture in Parkinson's patients, are also counted among other types of dementia. Prognosis-related data on dementia types other than Alzheimer's disease are limited in the literature. Determining the prognosis is important to support patients, anticipate long-term health problems, plan physician and healthcare provision, and support patients with dementia.In view of the lack of sufficient data on dementia types other than Alzheimer's disease, it is aimed to contribute to the literature on this subject and to determine the factors that may affect prognosis, morbidity and mortality in patients belonging to all dementia types.
- Conditions
- Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia of Alzheimer Type, Dementia Frontal, Dementia, Mixed
- Being tested
- Observational
- Medical subject headings
- Dementia, Dementia, Vascular, Lewy Body Disease, Mixed Dementias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Patients data were collected throughout the following time
| Study group | Role | What they receive |
|---|---|---|
| Dementia with Alzheimer | Patients previously diagnosed with Alzheimer disease would be included Receives: Other: Observational | |
| Dementia with Lewy Body Dementia | Patients previously diagnosed with Lewy Body Dementia would be included Receives: Other: Observational | |
| Dementia with Fronto-Temporal Dementia | Patients previously diagnosed with Fronto-Temporal Dementia would be included Receives: Other: Observational | |
| Dementia with Vascular Disease | Patients previously diagnosed with Dementia with Vascular Disease would be included Receives: Other: Observational | |
| Dementia with Parkinson Disease | Patients previously diagnosed with Dementia with Parkinson Disease would be included Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The event of death occuring during the follow-up period
Measured: 2 years
Mini-Mental State Examination
It was performed to assess mental status. It gives an overall opinion on cognitive domains and tests orientation, registration, attention and calculation, recall, and language. Total scores on Mini-Mental State Examination range from 0 to 30, higher scores show better cognitive performance.
Measured: 2 years
Barthel Index
It was used for assessing physical functioning as a part of the routine geriatric evaluation.where the ten performance items used. Those items defined as feeding, bathing, grooming, dressing, continence of bowel and bladder, toilet use, transfers (bed to chair and back), mobility (on level surfaces), and climbing stairs. Each item is scored on this scale, and the sum is obtained by adding the score of each item (range, 0-100; higher scores show better performance)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Jan 2000
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Neslihan Kayahan, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052450
- Sponsor's protocol ID
- 2021/290
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naharci MI, Kayahan Satis N, Ozsurekci C, Tasci I. Assessment of clinical features and coexisting geriatric syndromes in newly diagnosed dementia with Lewy bodies: a retrospective study in a tertiary geriatrics setting in Turkey. Eur Geriatr Med. 2023 Feb;14(1):19-27. doi: 10.1007/s41999-022-00727-0. Epub 2022 Dec 13.
PubMed 36512254
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Mortality, Morbidity and Prognosis in Dementia Patients
- ClinicalTrials.gov ID
- NCT05052450
- Acronym / sponsor ID
- 2021/290
- Conditions
- Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia of Alzheimer Type, Dementia Frontal, Dementia, Mixed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Sep 2021 (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.
Dementia; It is a chronic syndrome characterized by a general and progressive deterioration in cognition, including memory, orientation, language, and comprehension. The prognosis of this progressive and neurodegenerative disease after diagnosis may differ between individuals. In its broadest sense, the prognosis after a diagnosis of dementia; can be defined by shortening of life span, high level of cognitive and functional loss, decrease in quality of life and increased need for care. However, the prognosis of different types of dementia is highly variable. Because it is the most common type of dementia, studies are usually on Alzheimer's disease. It constitutes 50-75% of total dementia cases. Vascular dementia is the second most common cause of dementia and accounts for approximately 15% of dementia cases. Dementia with Lewy bodies constitutes 10-20% of the total dementia patients and ranks second among degenerative dementia types. Frontotemporal dementia, which mimics psychiatric disorders and has prominent behavioural problems, and Parkinson's disease-associated dementia, which is characterized by cognitive impairment that can be added to the existing picture in Parkinson's patients, are also counted among other types of dementia. Prognosis-related data on dementia types other than Alzheimer's disease are limited in the literature. Determining the prognosis is important to support patients, anticipate long-term health problems, plan physician and healthcare provision, and support patients with dementia.In view of the lack of sufficient data on dementia types other than Alzheimer's disease, it is aimed to contribute to the literature on this subject and to determine the factors that may affect prognosis, morbidity and mortality in patients belonging to all dementia types.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dementia with Alzheimer | – | Other: ObservationalPatients previously diagnosed with Alzheimer disease would be included |
| Dementia with Lewy Body Dementia | – | Other: ObservationalPatients previously diagnosed with Lewy Body Dementia would be included |
| Dementia with Fronto-Temporal Dementia | – | Other: ObservationalPatients previously diagnosed with Fronto-Temporal Dementia would be included |
| Dementia with Vascular Disease | – | Other: ObservationalPatients previously diagnosed with Dementia with Vascular Disease would be included |
| Dementia with Parkinson Disease | – | Other: ObservationalPatients previously diagnosed with Dementia with Parkinson Disease would be included |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with any kind of dementia and being older than 60 years would be included in the study
Key inclusion criteria (1 listed)
- Having applied to the Gulhane Training and Research Hospital Geriatrics Polyclinic Being diagnosed with Alzheimer or Lewy Body Dementia or Vascular Dementia or Fronto-Temporal Dementia or Parkinson Disease Dementia Being at the age of 60 years or older
Key exclusion criteria (1 listed)
- Being under the age of 60 Patients with insufficient recorded data and follow-up for the study Patients who either have diagnosis or follow-up in another center. Patients who have severe dementia that prevents applying for outpatient clinic
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 |
|---|---|---|
| ObservationalPatients data were collected throughout the following time | Other | Dementia with Alzheimer, Dementia with Fronto-Temporal Dementia, Dementia with Lewy Body Dementia, Dementia with Parkinson Disease, Dementia with Vascular Disease |
Primary outcome
Mortality
Time frame: 2 years
The event of death occuring during the follow-up period
Mini-Mental State Examination
Time frame: 2 years
It was performed to assess mental status. It gives an overall opinion on cognitive domains and tests orientation, registration, attention and calculation, recall, and language. Total scores on Mini-Mental State Examination range from 0 to 30, higher scores show better cognitive performance.
Barthel Index
Time frame: 2 years
It was used for assessing physical functioning as a part of the routine geriatric evaluation.where the ten performance items used. Those items defined as feeding, bathing, grooming, dressing, continence of bowel and bladder, toilet use, transfers (bed to chair and back), mobility (on level surfaces), and climbing stairs. Each item is scored on this scale, and the sum is obtained by adding the score of each item (range, 0-100; higher scores show better performance)
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 22 Sep 2021.
- Derived from this study: PubMed 36512254Naharci MI, Kayahan Satis N, Ozsurekci C, Tasci I. Assessment of clinical features and coexisting geriatric syndromes in newly diagnosed dementia with Lewy bodies: a retrospective study in a tertiary geriatrics setting in Turkey. Eur Geriatr Med. 2023 Feb;14(1):19-27. doi: 10.1007/s41999-022-00727-0. Epub 2022 Dec 13.
- Individual participant dataSharing planned: No
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Dementia, Vascular, run by Gulhane Training and Research Hospital.
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 1 inclusion and 1 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 22 Sep 2021. 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?
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?
Mortality (time frame: 2 years). The study lists 3 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 NCT05052450, which also lists 1 linked publication.
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 22 Sep 2021.