A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
About this study
This is a multicentre, randomized, double-blind, placebo-controlled, parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early AD followed by an Extension. The double-blind part is 72 weeks long, followed by an extension.
- Condition
- Alzheimer's Disease
- Tested
- VHB937, VHB937, Placebo
- Sponsor
- Novartis Pharmaceuticals
Who can join
- Age
- 50 to 85 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 50 years
- Maximum age: 85 years
- Study condition: Alzheimer's Disease
- Male or female participants 50 to 85 years of age
- Diagnosis of Mild Cognitive Impairment (MCI) due to AD or mild AD
- Clinical Dementia Rating (CDR) Global score of 0.5 or 1.0
- Confirmation of AD based on cerebral spinal fluid (CSF) biomarkers or amyloid PET imaging
- Reliable study partner who can accompany the participant at study visits
- If on symptomatic AD treatment (AChEIs/memantine), on a stable dose prior to starting study treatment
Exclusion 10
- Dementia due to a condition other than AD, including but not limited to, frontal temporal dementia, Parkinson's disease, dementia with Lewy bodies, Huntington disease, vascular dementia.
- History or current diagnosis of cardiac conditions or ECG abnormalities indicating significant risk of safety for participants in the study
- Transient ischemic attacks (TIA) or stroke occurring within 12 months
- Clinical evidence of liver or renal disease/injury
- Current major depressive episode that is not adequately controlled, history of schizophrenia, other chronic psychosis
- Significant neurological disease other than dementia (e.g. serious brain infection, traumatic brain injury, multiple concussions, epilepsy or recurrent seizures
- Presence of suicidal ideation within 6 months or suicidal behavior within 2 years before Screening
- Presence of cancer, HIV, Hep B, Hep C, uncontrolled thyroid disease, uncontrolled diabetes
- Taking any prohibited medications
- Other protocol-defined inclusion/exclusion criteria may apply
Where
74 sites, 74 recruiting
Novartis Investigative Site
Box Hill, Victoria, Australia
Novartis Investigative Site
Camperdown, New South Wales, Australia
Novartis Investigative Site
Heidelberg, Victoria, Australia
Novartis Investigative Site
Kogarah, New South Wales, Australia
Novartis Investigative Site
Nedlands, Western Australia, Australia
Novartis Investigative Site
London, Ontario, Canada
and 68 more sites on ClinicalTrials.gov
Contact
-
Novartis Pharmaceuticals
1-888-669-6682 novartis.email@novartis.com
-
Novartis Pharmaceuticals
+41613241111
Potential match only. Final eligibility is determined by the study team.