Memory Disorders Clinical Trials

Featured Study

The AHEAD Study

Alzheimer's disease (AD) is a progressive brain disorder that affects memory and thinking, and studies have shown that changes occur before the person exhibits any symptoms of AD-related memory loss. In people with Alzheimer's disease, an abnormal form of a protein called "amyloid" accumulates, resulting in an "amyloid plaque." As a result, researchers are developing specific tests to detect amyloid plaques before memory loss occurs, as studies have shown that people with normal memory performance who have elevated levels of brain amyloid are at increased risk for memory problems.

The AHEAD Study is made up of two clinical trials, A3 and A45. Both trials are examining whether the investigational treatment BAN2401 (Lecanemab) can reduce the risk of developing Alzheimer's disease dementia and brain amyloid accumulation when compared to placebo. BAN2401 binds to amyloid in the brain and has been shown to reduce its amount while also slowing cognition decline; thus, it may reduce the risk of developing AD dementia.

If you agree to participate, you will go through a screening process to determine if you are eligible for one of the two trials and to test the investigational treatment, and only people with intermediate or elevated levels of amyloid in their brain will be considered.

Eligible participants will be randomly assigned to either the investigational treatment (BAN2401) or a placebo. and will be subjected to a variety of procedures such as brain scans (MRI and PET), blood draws, and answering questionnaires as well as memory and daily functioning tests. The duration of participation is approximately 4 years.

Stanford Memory Disorders Clinical Trials

Active, recruiting:

Sponsor: Indiana University and NIA (LEADS)
Intervention
: N/A - Observational
Indication
: Early onset Alzheimer's Disease (EOAD), Early onset non-Alzheimer's Disease (EO-nonAD), and cognitively normal (CN)
Brief
Summary: A non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EO-nonAD) participants, and (3) cognitively normal (CN) control participants.
Clinicaltrials.gov identifier: NCT03507257
PI
: Sharon Sha, MD

Sponsor: Janssen Research & Development (Autonomy Study)
Intervention
: JNJ-63733657 (monoclonal anti-tau antibody)
Indication
: mild cognitive impairment and mild AD
Age
: 55-80 years old
Brief Summary: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer’s Disease
Clinicaltrials.gov identifier: NCT04619420
PI
: Sharon Sha, MD
Contact:
Viktoriya Bourakova - viktoriya.bourakova@stanford.edu - (650) 709-9041

Sponsor: Eisai and NIH (AHEAD 3-45 Study)
Intervention
: BAN2401 (monoclonal antibody binding to amyloid)
Indication
: Pre-clinical AD 
Brief Summary: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)
Clinicaltrials.gov identifier:
NCT04468659
PI
: Sharon Sha, MD
Contact
: https://studypages.com/s/the-ahead-study-440395/

Active, not recruiting:

Sponsor: Eli Lilly (Trailblazer Study)
Intervention
: Donanemab (monoclonal antibody binding to amyloid)
Protocol NCT#:
NCT04437511
PI: 
Sharon Sha, MD

Sponsor: Eisai (Clarity AD)
Intervention
: BAN2401 (monoclonal antibody binding to amyloid)
Indication
: MCI/Mild AD
Clinicaltrials.gov identifier: 
NCT03887455
PI
: Sharon Sha, MD
Contact:
 Viktoriya Bourakova, viktoriya.bourakova@stanford.edu

Sponsor: Cortexyme (Gain Study) 
Intervention
: COR388 (Gingipain inhibitor) 
Indication
: Mild to Moderate AD
Clinicaltrials.gov identifier: 
NCT03823404
PI
: Sharon Sha, MD

Sponsor: Biogen (Embark Study)
Intervention
: Aducanumab (Monoclonal antibody binding to amyloid)
Indication
: MCI/Mild AD (Recruiting by invitation only: participants who were previously enrolled in aducanumab trials) 
Clinicaltrials.gov identifier: 
NCT04241068
PI
: Sharon Sha, MD
Contact:
 Anthony Velasquez, anthgv@stanford.edu

Completing, not recruiting:

Sponsor: Biogen (Tango Study)
Intervention:
BIIB092 (Monoclonal antibody binding to tau)
Indication:
MCI/Mild AD
Clinicaltrials.gov identifier: 
NCT03352557
PI:
Sharon Sha, MD
Contact: 
Viktoriya Bourakova, viktoriya.bourakova@stanford.edu

Sponsor: Genentech (Tauriel Study)
Intervention
: RO7105705 (Monoclonal antibody binding to tau)
Indication
: MCI/Mild AD
Clinicaltrials.gov identifier: 
NCT03289143
PI
: Sharon Sha, MD
Contact:
 Jenn Gaudioso, jenn.gaudioso@stanford.edu

Sponsor: Genentech (Lauriet Study)
Intervention
: RO7105705 (Monoclonal antibody binding to tau)
Indication
: Moderate AD
Clinicaltrials.gov identifier: 
NCT03828747
PI
: Sharon Sha, MD
Contact: 
Jenn Gaudioso, jenn.gaudioso@stanford.edu

Sponsor: Novartis (Generations II Study)
Intervention:
 CNP520 (Active BACE-1 Inhibitor)
Target Population:
 Cognitively Unimpaired APOEHomozygotes or Amyloid Positive Heterozygotes
Clinicaltrials.gov identifier: 
NCT03131453
PI
: Sharon Sha, MD

Sponsor: Novartis (Generations I Study)
Intervention:
 CAD106 (Induces Active Antibody without activating Aβ-reactive T cells) and CNP520 (BACE-1 Inhibitor)
Target Population:
 Cognitively Unimpaired APOEHomozygotes
Clinicaltrials.gov identifier: 
NCT02565511
PI
: Sharon Sha, MD

Clinical trials contacts

memoryresearch@stanford.edu
(650) 724-8736

Sharon Sha, MD, MS
Clinical Associate Professor, Neurology & Neurological Sciences
Director, Memory Disorders Clinical Trials
ssha1@stanford.edu
(650) 723-5072