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The NADAPT Study: a Randomized Double-blind Trial of NAD Replenishment Therapy for Atypical Parkinsonism

Study acronym: NADAPT
StatusRecruiting
PhasePhase 2
Started2024-03-05
View on ClinicalTrials.gov ↗

Amendment history

2025-01-09
minor
Study Status, Oversight, Contacts/Locations, IPDSharing v4
Study sites2→3
2024-10-28
minor
Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations, References v3
Eligibility criteria+217 characters
[...] ormed 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 confirmingcannot nigrostriatalbe degenerationmore (inthan PSPtwo andyears MSA,old butat not necessarily in CBS)baseline. Meet the MDS criteria for possible or probable PSP; or Mee [...] r Meet the consensus criteria for probable or possible CBS. A time since diagnosis for PSP, MSA, or CBS of ≤ 3 years at baseline. A baseline PSPRS score of <40 for PSP, or baseline UMSARS sc [...] order; tumor or other space-occupying lesion. Treatment with/use [...] [...]
Secondary endpoints11 to 9 entries
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the CGI-C Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the CGI-S
2024-06-24
notable
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-01→confirmed 2024-03-05
Study sitesdetails revised at 2 of 2 sites
Collaborators10 to 11 entries
Vestre Viken HFHospital Trust Sykehuset Østfold HFOstfold Helse FørdeForde Elysium HFHealth
2023-12-11
minor
Study Status, Study Description, Study Design, Outcome Measures, Contacts/Locations v1
Secondary endpoints10 to 11 entries
Specific motor/non-motor symptoms, activities of daily function, and quality of life as measured by the MSA-QoL
Study descriptionrevised
[...] ients with MSA, and an undetermined number of patients with CDSCBS will be stratified by disease and randomized 1:1 per diseas [...]
Study sitescontacts updated at 2 of 2 sites
2023-11-29
minor
Original filing
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. Although PSP, MSA and CBS are rare diseases they constitute a major and mostly unaddressed challenge to health-care providers due to the severity of disease and lack of treatment. The main hypothesis for the NADAPT trial is that oral administration of NR can boost cellular NAD levels in the central nervous system of patients with PSP, MSA and CBS, and rectify metabolism and inhibit neurodegeneration, resulting in delayed disease progression and amelioration of symptoms for these patients. To test whether NR is a neuroprotective therapy for atypical parkinsonism, the investigators will perform the NADAPT clinical trial. The investigators will include 130 patients with Progressive supranuclear palsy (PSP), 165 patients with Multiple system atrophy (MSA) and an indeterminate number of patients with corticobasal syndrome (CBS). The participants will be stratified by disease into three cohorts and randomized to either 3000mg NR daily or placebo. The trial will include patients from all of Norway. Patients will be followed for 78 weeks with both in-clinic visits and decentralized safety measurements and reporting of patient reported outcomes (PROMs). After completion of the 78 weeks follow-up, patients are offered to continue in an open-label NR-only extension study, this extension study will last until follow-up is completed for the last patients in NADAPT.
Trial Details
NCT Number NCT06162013
Lead Sponsor Haukeland University Hospital
Collaborators: Oslo University Hospital, Akershus Universitetssykehus HF, Vestre Viken Hospital Trust, Sykehuset Ostfold, Nevro Arendal AS, Helse Forde, Helse Fonna, Universitetssykehuset Nord Norge HF, Helse Møre og Romsdal HF, Nordlandssykehuset HF, Elysium Health
Conditions Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Syndrome
Enrollment 330 participants
Start Date 2024-03-05
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2025-01-10