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New treatment option for Dementia
Official title The Swedish BioFINDER 2 Study
ClinicalTrials.gov ID: NCT03174938
What this study is testing
- What it's testing
- The Swedish BioFINDER 2 study is a new study that will launch in 2017 and extends the previous cohorts of BioFINDER 1 study (www.biofinder.se). BioFINDER 1 is used e.g.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 100. Healthy volunteers may be eligible.
You may be able to join if
- COHORT A: Cognitively healthy younger individuals (40-65 years of age) Age 40-65 years
- Absence of cognitive symptoms as assessed by a physician with special interest in cognitive disorders.
- MMSE score 27-30 at screening visit.
- Do not fulfill the criteria for MCI or any dementia according to DSM-V.
- Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and...
You likely can't join if
- Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- Current significant alcohol or substance misuse.
- Significant neurological or psychiatric illness.
- Refusing lumbar puncture, MRI or PET. COHORT B: Cognitively healthy elderly individuals (66-100 years of age) INCLUSION CRITERIA
- Age 66-100 years
- Absence of cognitive symptoms as assessed by a physician with special interest in cognitive disorders.
See the full eligibility criteria
Who can join
- COHORT A: Cognitively healthy younger individuals (40-65 years of age) Age 40-65 years
- Absence of cognitive symptoms as assessed by a physician with special interest in cognitive disorders.
- MMSE score 27-30 at screening visit.
- Do not fulfill the criteria for MCI or any dementia according to DSM-V.
- Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests.
What rules you out
- Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- Current significant alcohol or substance misuse.
- Significant neurological or psychiatric illness.
- Refusing lumbar puncture, MRI or PET. COHORT B: Cognitively healthy elderly individuals (66-100 years of age) INCLUSION CRITERIA
- Age 66-100 years
- Absence of cognitive symptoms as assessed by a physician with special interest in cognitive disorders.
- MMSE score 26-30 at screening visit.
- Do not fulfill the criteria for MCI or any dementia according to DSM-V.
- Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests. EXCLUSION CRITERIA
- Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- Current significant alcohol or substance misuse.
- Significant neurological or psychiatric illness.
- Refusing lumbar puncture, MRI or PET. COHORT C: Subjective cognitive decline and mild cognitive impairment INCLUSION CRITERIA
- Age 40-100 years.
- Referred to the memory clinics due to cognitive symptoms experienced by the patient and/or informant. These symptoms do not have to be memory complaints, but could also be executive, visuospatial, language, praxis...
- MMSE score of 24 - 30 points.
- Do not fulfill the criteria for any dementia (major neurocognitive disorder) according to DSM-V.
- The medical doctor (after clinical assessments, cognitive testing, CSF analyses and structural brain imaging) believes the cognitive complaints are caused by an incipient neurocognitive disorder of any sort. This is...
- Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests. EXCLUSION CRITERIA
- Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- Current significant alcohol or substance misuse.
- Refusing lumbar puncture, MRI or PET. COHORT D: Dementia due to Alzheimer's disease INCLUSION CRITERIA
- Age 40-100 years.
- Referred to the memory clinics due to cognitive symptoms experienced by the patient and/or informant. These symptoms do not have to be memory complaints, but could also be executive, visuospatial, language, praxis or...
- MMSE score of 12-26 points.
- Fulfill the criteria for dementia (major neurocognitive disorder) due to Alzheimer's disease (DSM-V).
- Speaks and understands Swedish to the extent that an interpreter was not necessary for the patient to fully understand the study information and cognitive tests. EXCLUSION CRITERIA
- Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- Current significant alcohol or substance misuse.
- Refusing lumbar puncture, MRI or PET. COHORT E: Other dementias INCLUSION CRITERIA
- Age 40-100 years.
- Fulfill the criteria for dementia (major neurocognitive disorder) due to FTD, PDD, DLB or subcortical VaD alternatively the criteria for PD, PSP, MSA, CBS or ALS.
- Speaks and understands Swedish to the extent that an interpreter was not necessary for the patient to fully understand the study information and cognitive tests. EXCLUSION CRITERIA
- Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- Current significant alcohol or substance misuse.
- Refusing lumbar puncture, MRI or PET.
The study team makes the final eligibility decision.
Where it's taking place
- Ängelholm, Sweden
- Malmö, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ängelholm, Sweden; Malmö, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.