Clinical trials: Prodromal Stage
Alzheimer's Disease
A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD.
- Trial name
- CREAD (NCT02670083)
- Testing
- Crenezumab
- Where
- 196 sites in United States, Australia and 28 more
- Volunteers
- 813 people
- Sponsor
- Hoffmann-La Roche
Mild Cognitive Impairment, Alzheimer Disease
INTERCEPTOR Project: From MCI to Dementia
In the next years a number of phase 2-3 trials which utilize experimental drugs possibly disease modifying for Alzheimer Dementia will reach their conclusion.
- Trial name
- INTERCEPTOR (NCT03834402)
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- Catholic University of the Sacred Heart
Hippocampal Hyperactivation, Prodromal Alzheimer Disease
Levetiracetam for Persons at Risk for Alzheimer's Disease
The goal of this clinical trial is to investigate whether very small doses of a drug called levetiracetam (LEV) may reduce elevated brain signaling in individuals who are at an increased risk for developing Alzheimer's Disease…
- Trial name
- ALEVIATE-2 (NCT07477431)
- Testing
- Levetiracetam (LEV)
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- Sunnybrook Health Sciences Centre
Alzheimer Disease (AD)
Evaluation Comparing Tau PET Radiotracers, [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in Subjects With Normal Cognition or Prodromal to Moderate Alzheimer's Disease
The study aims to compare tau targeted radiotracers [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in subjects with normal cognition or prodromal to moderate Alzheimer's disease (AD).
- Trial name
- NCT04566003
- Testing
- [18F]GTP1, [18F]PI-2620, [18F]MK-6240
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Genentech, Inc.
Alzheimer Disease
Neuroelectrical Biomarkers for Alzheimer's Disease Stages
Recent diagnostic criteria for Alzheimer's disease (AD) recognize an extended spectrum of AD stages as part of the disease, including a preclinical stage.
- Trial name
- ESTIMATE (NCT01880151)
- Testing
- EEG
- Where
- France
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
At Risk Mental State (ARMS), Psychosis
Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States
This is a randomized double-blind placebo controlled trial which aims to evaluate the efficacy and tolerability of minocycline and Omega-3 fatty acids for patients with ARMS.
- Trial name
- NAYAB (NCT02569307)
- Testing
- Minocycline, Omega-3 fatty acids, Minocycline Plus Omega-3 fatty acids
- Where
- 7 sites in Pakistan
- Volunteers
- 326 people
- Sponsor
- Pakistan Institute of Living and Learning
REM Sleep Behavior Disorder, Parkinson Disease
North American Prodromal Synucleinopathy Consortium Stage 2
This study will enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.
- Conditions
- REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Dementia, Dementia With Lewy Bodies
- Trial name
- NAPS2 (NCT05826457)
- Where
- 9 sites in United States, Canada
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Alzheimer Disease, Preclinical Alzheimer's Disease
Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech - FUTURE Extension
The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech, can predict change in PACC5 between baseline and +12 month follow up across all four Arms, as…
- Conditions
- Alzheimer Disease, Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer's Disease (Incl Subtypes)
- Trial name
- AMYPRED-FUTURE (NCT04846426)
- Where
- 4 sites in United Kingdom
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Novoic Limited
Alzheimer Disease, Preclinical Alzheimer's Disease
Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech
The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech can detect amyloid-specific cognitive impairment in early stage Alzheimer's disease, as measured…
- Conditions
- Alzheimer Disease, Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer's Disease (Incl Subtypes)
- Trial name
- AMYPRED (NCT04828122)
- Where
- 4 sites in United Kingdom
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Novoic Limited
Alzheimer's Disease
A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease
The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).
- Trial name
- ExpeditionPRO (NCT02760602)
- Testing
- Solanezumab
- Where
- 193 sites in United States, Canada and 11 more
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
Amnestic Mild Cognitive Impairment, Alzheimer's Disease
Efficacy and Safety Trial of Verubecestat (MK-8931) in Participants With Prodromal Alzheimer's Disease (MK-8931-019)
This study consists of two parts, Part 1 and Part 2. Part 1 assesses the efficacy and safety of verubecestat (MK-8931) compared with placebo administered for 104 weeks in the treatment of amnestic mild cognitive impairment (aMCI)…
- Conditions
- Amnestic Mild Cognitive Impairment, Alzheimer's Disease, Prodromal Alzheimer's Disease
- Trial name
- APECS (NCT01953601)
- Testing
- Verubecestat 12 mg (Parts 1 and 2), Verubecestat 40 mg (Parts 1 and 2)
- Volunteers
- 1,454 people
- Sponsor
- Merck Sharp & Dohme LLC
Alzheimers Disease
Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to…
- Trial name
- NCT04639050
- Testing
- RO7126209
- Where
- 37 sites in United States, Australia and 7 more
- Volunteers
- 241 people
- Sponsor
- Hoffmann-La Roche
Dementia With Lewy Bodies
Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial
This is a confirmatory investigational medicinal product (IMP) study to investigate the effects on cognition, functional decline and on neuropsychiatric symptoms of the Glucocerebrosidase (GCase) enhancing chaperone ambroxol in…
- Trial name
- ANeED (NCT04588285)
- Testing
- Ambroxol
- Where
- 8 sites in Norway
- Volunteers
- 180 people
- Sponsor
- Helse Fonna
Hereditary Spastic Paraplegia, Hereditary, Spastic Paraplegia, Autosomal Dominant
The preSPG4 Study - Studying the Prodromal and Early Phase of SPG4
Study goals 1. Prospective longitudinal data on progression in the natural course of SPG4 in presymptomatic mutation carriers prior to clinical disease onset and in early stages of disease 2.
- Trial name
- NCT03206190
- Testing
- SPRS Score and clinical signs, Cognition Testing using CANTAB, Lumbar Puncture and blood draw
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University Hospital Tuebingen
Alzheimer's Disease
A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)
The purpose of the study is to investigate the effect of bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer's Disease…
- Trial name
- NCT04867616
- Testing
- Bepranemab
- Where
- 103 sites in United States, Belgium and 8 more
- Volunteers
- 466 people
- Sponsor
- UCB Biopharma SRL
Amyloid Plaque, Beta-Amyloid
A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome.
- Conditions
- Amyloid Plaque, Beta-Amyloid, DSAD, Prodromal Alzheimer's Disease
- Trial name
- NCT05462106
- Testing
- ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a
- Where
- 26 sites in United States, Spain and 1 more
- Volunteers
- 304 people
- Sponsor
- AC Immune SA
Alzheimer's Disease
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
This clinical trial is recruiting people who either are at risk of AD - have build-up of beta-amyloid, but have no clinical symptoms, or with a diagnosis of mild cognitive impairment.
- Trial name
- NCT06402838
- Testing
- RO7269162
- Where
- 46 sites in Chile, Denmark and 7 more
- Volunteers
- 256 people
- Sponsor
- Hoffmann-La Roche
Parkinson Disease, Prodromal Stage
Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands
The goal of this clinical trial is to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with isolated Rapid Eye Movement…
- Conditions
- Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases, Parkinsonian Disorders
- Trial name
- Slow-SPEED-NL (NCT06193252)
- Testing
- Increase of physical activity volume and intensity with the use of a motivational smartphone application
- Where
- Netherlands
- Volunteers
- 110 people
- Sponsor
- Radboud University Medical Center
Alzheimer Disease
Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD.
- Trial name
- NCT03444870
- Testing
- Gantenerumab
- Where
- 172 sites in United States, Australia and 13 more
- Volunteers
- 1,053 people
- Sponsor
- Hoffmann-La Roche
Schizophrenia, Psychosis
Multi-site Communication Deficits in Schizophrenia
Multi-site Communication Deficits Underlying Cognitive Dysfunction in the Prodromal Phase and First Episode of Schizophrenia
- Trial name
- NCT01317121
- Where
- Germany
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf