Brain Health & Memory Clinical Trials

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

The purpose of this study (ALLFTD) is to understand how Frontotemporal Lobar Degeneration (FTLD) syndromes progress over time, and to develop new tools to help with diagnosis and eventual treatment. The study is enrolling patients with FTLD syndromes. Additionally, the study is enrolling healthy members of families where there is a strong family history of FTLD or known FTLD-associated genetic mutation.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene. 

Principal Investigator: Brian Appleby, MD

Main Eligibility Criteria:

• Is a known carrier of a heterozygous loss-of-function GRN mutation causative of FTD with a global CDR® plus NACC FTLD score of 0 to 2, and:
  • A CDR® plus NACC FTLD-SB score ≤0.5 with an elevated level of serum NfL, or
  • A CDR® plus NACC FTLD-SB score of >0.5 with 1 or more of the 6 behavioral/cognitive symptoms required for a diagnosis of possible bvFTD (Rascovsky 2011), or a diagnosis of PPA (Gorno-Tempini 2011).
• Age 25 to 85 years, inclusive, at Screening.
• Must have study partner

Study Coordinator: Susie Sami: 216-464-6467 or Susie.Sami@uhhospitals.org

216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 (lecanemab) 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)

216-week treatment, multicenter, double-blind, placebo-controlled, parallel-treatment arm study in subjects with preclinical AD and elevated amyloid (A45 Trial) and subjects with early preclinical AD and intermediate amyloid beta (Aβi) (A3 Trial). For the purpose of this protocol, these subjects are defined as “early preclinical AD”, and the amyloid levels are termed “intermediate”.

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 .

Study Title: Trial Ready Cohort for the Prevention of Alzheimer's Dementia (TRC-PAD)

Principal Investigator: Rajeet Shrestha, MD

Study Purpose: (Trial-Ready Cohort for the Prevention of Alzheimer’s Dementia the purpose of the study is to identify and enroll people into Alzheimer’s therapeutic trials. TRC-PAD volunteers become part of a group, known as a cohort, regularly assessed at twice yearly in-person visits until they may become eligible for an Alzheimer’s disease research study.

Basic Eligibility Criteria: 

• Age 50-85 (inclusive)
• Global CDR score of 0 or 0.5 and no diagnosis of dementia
• Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication).

Study Coordinator: Susie Sami: 216-464-6467 or Susie.Sami@uhhospitals.org

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

Study Coordinator: Mary Andrews, 216-844-2386

Principal Investigator: Rajeet Shrestha, MD

Study Purpose: The S-CitAD study is a multi-center study developing an algorithm for the treatment of clinically significant agitation in patients with Alzheimer's dementia (MMSE 5-26). Enrolled patients and their caregivers first receive a psychosocial intervention over three weeks. If after three weeks they are not improved they randomize to escitalopram versus placebo and are followed for a total of 6 months. Participants who improve are also followed open label. A major focus of the study is defining sub-groups of patients who respond to the psychosocial intervention or the drug. As such a suite of clinical and blood based biomarkers are assessed at baseline and overtime. In addition to the main study, the project has a blood banking supplement, an actigraphy supplement and a COVID supplement.

Basic Eligibility Criteria:

• Alzheimer’s dementia diagnosed clinically by the National Institute on Aging (NIA) and the Alzheimer’s Association (2011 NIA/AA criteria)
• Mini-Mental State Examination (MMSE) score of 5-28 Inclusive
• Meets the International Psychogeriatric Association (IPA) Provisional criteria for agitation in cognitive disorders
• Clinically significant agitation/aggression as assessed by the Neuropsychiatric Inventory (NPI)

Study Coordinator: Srishti Ahuja: 775-443-6770 or Srishti.ahuja@uhhospitals.org