By Randolph Fillmore
Research teams at the University of Florida (UF) and University of Arizona (UA) to test a novel, relatively low cost, low risk, and potentially high impact therapeutic intervention in older adults who are at increased risk for Alzheimer's disease. The intervention involves transcranial and intranasal delivery of near infrared (NIR) light via light emitting diodes, also called photobiomodulation.
Estimated Enrollment: 168 participants
Participants who meet eligibility criteria will be randomized to the Active or Sham condition. Participant arrives, she/he will be randomized to Active or Sham groups depending on covariate characteristics (age, education, sex) and the cumulative distribution of assignments regarding these variables at that point.
Primary Purpose: Prevention
Official Title: Revitalizing Cognition in Older Adults at Risk for Alzheimer's Disease With Near-Infrared Photobiomodulation
Study Start Date: August 12, 2020; Estimated Study Completion Date: January 2025
Contact: Dawn Bowers, Ph.D. 352-273-6152 firstname.lastname@example.org
Contact: Adam J Woods, Ph.D. 352-294-5842 email@example.com
University of South Florida (USF) - Tampa
Recent data analyses from the Advanced Cognitive Training in Vital Elderly study (ACTIVE) indicate that a specific cognitive intervention, speed of processing training (SPT), significantly delays the incidence of cognitive impairment across 10 years. The primary contribution of the proposed research will be the determination of whether this cognitive training technique successfully delays the onset of clinically defined MCI or dementia across three years.
Inclusion Criteria: Be age 65 or older at time of consent; Have ability to speak and understand English; Report adequate sensorimotor capacity to perform the computer exercises; Report adequate visual capacity to read from a computer screen at a typical viewing distance; Show adequate auditory capacity to understand conversational speech; Show adequate motor capacity to touch a computer screen or control a computer mouse.
Contact: Jerri Edwards, PhD 813.974.8572 firstname.lastname@example.org
Contact: Alisa Houseknecht, PhD, 813.974.8572, email@example.com
The USF Health Byrd Alzheimer's Center and Research Institute, Tampa
The primary purpose of this study is to determine whether treatment with BAN2401 is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with BAN2401 is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial).
Ages Eligible for Study: 55 Years to 80 Years (Adult, Older Adult)
Inclusion criteria: Participants must meet all criteria to be included in this study:
Male or female, age 55 to 80 years inclusive at the time of informed consent
Those 55 to 64 must have 1 of the following additional risk factors, given the relatively low rates of amyloid positivity less than (<) 65 years:
First degree relative diagnosed with dementia onset before age 75, or
Known to possess at least 1 apolipoprotein E4 variant (APOE4) allele, or
Known before screening to have elevated brain amyloid according to previous PET or cerebrospinal fluid (CSF) testing (see more inclusion information https://www.clinicaltrials.gov/ct2/show/NCT04468659?recrs=a&cond=Alzheimer+Disease&cntry=US&state=US%3AFL&draw=2&rank=10)
Interventional (Clinical Trial)
Estimated Enrollment: 1400 participants
Allocation: Randomized, drug or placebo
Primary Purpose: Treatment
Official Title: AHEAD 3-45 Study: 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)
Actual Study Start Date: July 13, 2020; Estimated Completion Date: October 25, 2027
Contact: Contact: Eisai Medical Information +1-888-274-2378 firstname.lastname@example.org
Contact: ACTC Recruitment Unit email@example.com
Johns Hopkins University, Baltimore and Miami Jewish Health, Miami
There is a great need for better interventions that target Agit-AD, a major source of patient disability as well as caregiver burden and stress, particularly in the case of moderate to severe agitation. This pilot trial could open the door to "re-purposing" Dronabinol (Marinol®) as a novel and safe treatment for Agit-AD with significant public health impact.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment:160 participants
Actual Study Start Date: March 1, 2017; Estimated Study Completion Date: May 2022
Inclusion: Diagnosis of Dementia due to AD; Presence of Agit-AD as defined by the provisional criteria from the International Psychogeriatric Association (IPA). The definition requires the presence of cognitive impairment, evidence of emotional distress, one of three observable types of behavior (excessive motor activity, verbal aggression, physical aggression), requires that the behavior cause excess disability, and notes that the behaviors cannot be solely attributable to another disorder such as psychiatric illness, medical illness, or effects of substance use. (more information: https://www.clinicaltrials.gov/ct2/show/NCT02792257?recrs=a&cond=Alzheimer+Disease&cntry=US&state=US%3AFL&draw=2&rank=9
Contact: Maria Isesalaya, MBA, BS 305-751-8626 ext 64108 firstname.lastname@example.org
Contact: Ricardo Castaneda, PharmD, CCRC 305-751-8626 ext 64199 email@example.com
For more Florida AD clinical trials click on: https://www.clinicaltrials.gov/ct2/results?cond=Alzheimer+Disease&cntry=US&state=US%3AFL&Search=Apply&recrs=a&age_v=&gndr=&type=&rslt=
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