BridgeMD
New treatment option for Progressive Supranuclear Palsy
Official title The NADAPT Study: a Randomized Double-blind Trial of NAD Replenishment Therapy for Atypical Parkinsonism
ClinicalTrials.gov ID: NCT06162013
What this study is testing
- What it's testing
- Progressive supranuclear palsy (PSP), Multiple system atrophy (MSA) and corticobasal syndrome (CBS) are severe neurodegenerative diseases with rapid progression and no effective treatment. Patients quickly succumb to increasing motor and non-motor symptoms and survival ranges from \~3 years to \~10 years.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 85
You may be able to join if
- Participant must understand the nature of the study and be able to provide written, informed consent.
- Male or female aged 30-85 years at baseline.
- 123I-Ioflupane dopamine transporter imaging (DaTSCAN) or FDOPA- PET has been performed. A negative DaTSCAN cannot be more than two years old at...
- Meet the MDS criteria for possible or probable PSP; or
- Meet the MDS criteria for clinically possible or probable MSA; or
You likely can't join if
- Insufficient fluency in local language to complete neuropsychological and functional assessments.
- Evidence of differential diagnoses to PSP, MSA or CBS including: PD; dementia with Lewy bodies; Alzheimer's disease; motor neuron disease; history of...
- Presence of other significant neurological or psychiatric disorders including (but not limited to) psychotic disorders; severe bipolar or unipolar...
- Treatment with/use of NR or any investigational drugs or device, within 90 days of screening.
- A history of alcohol or substance abuse within 1 year prior to baseline (Visit 1) and deemed to be clinically significant by the site investigator
- Any active neoplastic malignancy (other than non-metastatic dermatological conditions) within two years of the screening visit (Visit 0) or current...
See the full eligibility criteria
- Participant must understand the nature of the study and be able to provide written, informed consent.
- Male or female aged 30-85 years at baseline.
- 123I-Ioflupane dopamine transporter imaging (DaTSCAN) or FDOPA- PET has been performed. A negative DaTSCAN cannot be more than two years old at baseline.
- Meet the MDS criteria for possible or probable PSP; or
- Meet the MDS criteria for clinically possible or probable MSA; or
- Meet the consensus criteria for probable or possible CBS.
- A baseline PSPRS score of \<40 for PSP, or baseline UMSARS score \< 3 on items: 1, 2, 7-9.
- Score ≥ 20 on the Mini-Mental State Examination (MMSE) at screening.
- Able to ambulate independently or with assistance defined as the ability to take at least 5 steps with a walker (guarding is allowed provided there is no contact) or the ability to take at least 5 steps with the...
- Insufficient fluency in local language to complete neuropsychological and functional assessments.
- Evidence of differential diagnoses to PSP, MSA or CBS including: PD; dementia with Lewy bodies; Alzheimer's disease; motor neuron disease; history of repeated and/or major stroke; history of repeated and/or severe brain...
- Presence of other significant neurological or psychiatric disorders including (but not limited to) psychotic disorders; severe bipolar or unipolar depression; seizure disorder; tumor or other space-occupying lesion.
- Treatment with/use of NR or any investigational drugs or device, within 90 days of screening.
- A history of alcohol or substance abuse within 1 year prior to baseline (Visit 1) and deemed to be clinically significant by the site investigator
- Any active neoplastic malignancy (other than non-metastatic dermatological conditions) within two years of the screening visit (Visit 0) or current clinically significant hematological, endocrine, cardiovascular, renal...
- Clinically significant laboratory abnormalities at screening that cannot be corrected to baseline and that is deemed incompatible with study participation by investigator.
- History of deep brain stimulator surgery other than sham surgery for deep brain stimulation (DBS) clinical trial.
- History of a clinically significant medical condition that would interfere with the subject's ability to comply with study instructions, would place the subject at increased risk, or might confound the interpretation of...
- Severe dysphagia with inability to swallow study-drug safely at baseline.
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Oslo, Norway
- Bergen, Vestland, Norway
- Drammen, Norway
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, 30 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Oslo, Norway; Bergen, Vestland, Norway; Drammen, Norway. 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.