Brain Health & Memory Clinical Trials

Alzheimer's Disease Neuroimaging Initiative 4 (ADNI4) In-Clinic Cohort

Principal Investigator: Charles Duffy, MD

StudyID: 2023-01189

Study Purpose: The purpose of this study is to encourage new investigation and to increase the pace of discovery in the race to prevent, treat and one day cure Alzheimer’s disease.

Main Eligibility Criteria:

• You may be able to help if you are 55 to 90 years of age and:
• Are in good general health
• Are cognitively normal (preferred to be minorities), have Mild Cognitive Impairment (MCI) or have been diagnosed with mild dementia due to Alzheimer's
• Are willing and able to undergo in-clinic assessments, memory testing and other test procedures
• Have a study partner who can accompany you to all clinic visits
• Are fluent in English or Spanish

Study Coordinators: Varinder Kaur (216-464-6221) or Parianne Fatica (216-464-6474)

AHEAD Plasma Extension (APEX)

Principal Investigator: Paula Ogrocki, PhD

StudyID: 2023-01324

Main Eligibility Criteria:

• Previously consented to participate in A3-45 screening.
• Has A3-45 screening plasma biomarker results required for determining eligibility to participate in the A3-45 trial.
• If an amyloid PET scan was conducted in A3-45, the scan was determined to be below the 20 centiloid cutpoint required for eligibility into the treatment arms of the A3 or A45 trial.
• As assessed by the site Pl, participant is likely to be able to comply with the protocol, including completion of all required procedures for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy in English or Spanish sufficient for compliance with required testing procedures.

Study Purpose: The APEX study is a multicenter, observational study designed to capture longitudinal follow up of plasma biomarkers and cognitive and functional assessments on individuals who screen failed in the AHEAD study over approximately 4 years. Participants will be enrolled across three groups, namely, Group A: participants who are discordant on screening (Plasma+/PET-), Group B: participants who are concordant on screening (Plasma-/PET-), and Group C:participants selected from the individuals who previously screen failed prior to PET for the AHEAD study with oversampling of racial and ethnic populations underrepresented in AD clinical trials.

Study Coordinator: Parianne Fatica (216-464-6474)

CogRX (START Study)

Synaptic Therapy Alzheimer’s Research Trial (START): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer’s Disease over 18 Months

Principal Investigator: Charles Duffy, MD, PhD

StudyID: 2023-01383

Study Purpose: The START Study is a Phase 2 randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of CT1812, an investigational drug, in individuals with Mild Cognitive Impairment (MCI) or mild Alzheimer’s Disease (AD). CT1812 is intended to target underlying amyloid pathology in AD by disrupting the binding of toxic amyloid-beta oligomers to neuronal receptors, potentially slowing cognitive decline and improving clinical outcomes in this population. M

Main Eligibility Criteria:

• Age: 50-85 years
• Cognitive Function: Clinical Dementia Rating (CDR) score of 0.5 or 1, indicating very mild to mild cognitive impairment
• Cognitive Assessment: Mini-Mental State Examination (MMSE) score between 20-30, reflecting mild impairment
• Memory Performance: Logical Memory II test score at least 1.5 standard deviations below education-adjusted norms, identifying memory impairment relevant to early-stage AD.

Study Coordinator: Srishti Ahuja (216- 464-6206)

Principal Investigator: Brian Appleby, MD

Study Purpose: The goal of the Cleveland Alzheimer's Disease Research Center (CADRC) will be able to increase the speed of research being done on aging related diseases. Our goal is to develop a group of subjects diagnosed with different forms of dementia, including:

• Alzheimer's disease/Mild Cognitive Impairment (MCI)
• Lewy Body Dementia
• We will also enroll cognitively normal individuals with and without a family history of dementia

We will follow patients over time collecting detailed clinical information, biospecimens and imaging data with the goal of better understanding the biology of different forms of dementia. The establishment of a CADRC will also promote additional future research, including therapeutic trials, by having a readily available supply of samples available.

Basic Eligibility Criteria:

• Age 18 and older
• Have AD/MCI/Lewy Body Dementia or are cognitively normal
• Can participate in annual visits with cognitive testing and research blood draw

Study Coordinators: 

• Lyndsi Powell: (216) 464-6204 or Lyndsi.Powell@UHhospitals.org
• Gordon Williams: (216) 464-6434 or Gordon.Williams2@UHhospitals.org
• Susie Sami: (216) 464-6467 orSusie.Sami@uhhospitals.org

Alzheimer’s Clinical Trial Consortium for Down Syndrome (ACTC-DS) - Trial-Ready Cohort - Down Syndrome (TRC-DS)

The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 non-demented adults (ages 35-55) with Down syndrome (DS) into a trial ready cohort (TRC). Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression .

Vascular reactivity study in dementia patients and age-matched controls

The purpose of this research study is to determine if there are differences in blood flow between people diagnosed with age-related dementia and subjects of a similar age with no diagnosed dementia. The study is being funded by the American Heart Association and the Allen Foundation.

Study Title: A Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION717 in Patients with Prion Disease

Principal Investigator: Brian Appleby, MD

Study ID#: Pro0007291

Basic Eligibility Criteria:

• Aged ≥ 18 at the time of informed consent
• A confirmed diagnosis of probable or definite prion disease determined by an independent adjudication committee
• An MRC-PDRS score of ≥ 15 at the time of Screening
• Have a caregiver who is at least 18 years of age, willing to sign an informed consent, accompany the patient to all trial visits (to the best of their ability), willing to be available to the Study Center by phone, and is (in the opinion of the Investigator) likely to remain sufficiently knowledgeable of patient’s condition to respond to inquiries about the patient, such as providing information related to the patient’s cognitive and functional abilities, for the duration of the trial

Foiling Deadly Prions
Can the course of fatal prion diseases be changed by removing the protein before it goes bad?