N-DOSE AD: Alzheimer Hastalığında Nikotinamid Ribozid Doz Optimizasyonu Çalışması

Sade dilde özet

Bu çalışma, Alzheimer hastalığı (Alzheimer's disease) olan kişilerde Nicotinamide Riboside adlı takviyenin en uygun dozunu araştırmakta ve karşılaştırma için plasebo (Placebo) kullanmaktadır. Çalışmaya, kılavuz ölçütlerine göre olası Alzheimer tanısı almış, 50-85 yaş arası ve belirli incelemelere uygun kişiler katılabilmiştir. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Haukeland University Hospital

Müdahale

Placebo, Nicotinamide Riboside supplementation 1000mg daily in total, Nicotinamide Riboside dose escalation (up to 3000 mg daily in total)

Başlangıç

22.11.2022

Tahmini bitiş

05.06.2025

Ülkeler

Norway

İlgili genler

Merkezler

• Bergen, Norway
• Bergen, Norway

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* The following condition must apply to the prospective patient at screening prior to receiving study agent:

  * Diagnosis of probable Alzheimer Disease (AD) according to the core clinical criteria updated in the National Institute on Aging (NIA) and Alzheimer's Association guidelines.
  * Biomarker evidence consistent with AD neuropathologic change, defined by cerebrospinal fluid (CSF) markers.
  * Diagnosed with AD within two years from enrollment.
  * Clinical Dementia Rating (CDR) 0.5-1 (inclusive) at enrollment.
  * Age 50 to 85 years (inclusive) at the time of enrollment.
  * A study partner (i.e. a family member or a friend) able to provide study data and assist the participant in the study drug administration, i.e. contact ≥ 3 times weekly.
  * Capacity to provide written informed consent for study participation defined as Montreal Cognitive Assessment (MoCA) score ≥ 16 or Mini Mental State Evaluation (MMSE) score ≥ 20. MMSE or MoCA must have been performed within 6 months prior to baseline. If there is any doubt regarding the participants capacity to give informed consent we will ask for an independent evaluation by a consultant clinician who is not associated with the N-DOSE AD study.
  * Cholinesterase inhibitors and memantine can be used if stable for 8 weeks prior to baseline visit.
  * Able to undergo lumbar puncture.
  * Able to undergo magnetic resonance imaging (MRI)

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

* Diagnosis of dementia other than probable AD.
* Comorbidity that precludes study participation or data interpretation.
* Any psychiatric disorder that would interfere with compliance in the study.
* Any severe somatic illness that would interfere with compliance and participation in the study.
* Use of high dose vitamin B3 supplementation within 30 days of enrollment.
* Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
* Current treatment with Oral Anti-coagulation Therapies
* Implants that preclude MRI examinations, e.g. DBS, pacemaker