Identification of Patients With a High Probability of Meeting Eligibility Criteria for an Alzheimer's Disease Clinical Trial (APHELEIA)

Alzheimer Disease Clinical Trial

Official title:

Identification of Mild Cognitive Impairment (MCI) and Early Alzheimer's Disease (AD) Patients With a High Probability of Meeting Eligibility Criteria for a Therapeutic Alzheimer's Disease Clinical Trial (APHELEIA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05364307
• Other study ID #: Apheleia-001
• Status: Active, not recruiting
• Start date: June 13, 2022
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Global Alzheimer's Platform Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Apheleia-001 is a prescreener that aims to identify and characterize participants with reported cognitive impairment using demographic information, clinical history, brief cognitive assessments, and blood-based biomarkers to distinguish appropriate participants for referral to a therapeutic AD clinical trial.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• 1. Participants and/or a legally authorized representative (LAR) must provide signed and dated informed consent and authorization to use personal health information in accordance with local and national guidance and regulations;

2. Male or female 50 to 90 years of age (inclusive) at the time of consent;

3. Participants must have a Mini-Mental State Exam (MMSE) score of 20 to 28 inclusive;

4. Progressive cognitive complaints must be reported by participant or caregiver;

5. Participants must be willing to comply with all procedures as outlined in the informed consent, including blood sampling, genetic testing, and storage of biospecimens for future research;

6. Fluency in the language of the tests used at the site;

7. Participants must be interested in participating in clinical research.

Exclusion Criteria:

• 1. Participants who, in the opinion of the Investigator, have serious or unstable medical conditions that would prohibit their completion of all prescreening procedures and data collection;

2. Participants who are currently enrolled in another clinical study.

3. Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial;

4. Participants who have reported or have a known negative amyloid PET scan in the past 24 months;

5. Participants with history of stroke within 6 months of prescreening;

6. Participants with an uncontrolled seizure disorder, unexplained blackouts, OR history of a seizure within 6 months (subjects with a history of pediatric febrile seizure, benign rolandic epilepsy may participate);

7. Participants with a history or evidence of a malignancy within the 2 years prior to prescreening. Subjects with indolent malignancies (e.g., basal cell carcinoma or squamous cell carcinoma) or malignancies considered to be cured and not actively treated with anti-cancer therapy or radiotherapy are permitted to enroll;

8. Participants with known or suspected alcohol or drug abuse or dependence within 2 years of prescreening;

9. Participants with a reported suicidal attempt within 2 years of prescreening), or any unstable psychiatric symptoms (e.g., uncontrolled depression);

10. Participants who have participated in a clinical trial of any potential disease modifying AD treatment and received active drug within 6 months prior to prescreening;

11. Participants who have any neurological disorder affecting the central nervous system, other than AD, that may be contributing to cognitive impairment (e.g., Parkinson's disease, other dementias, multiple concussions or seizures) as deemed significant by the Investigator;

12. Participants with known history of hepatitis C virus, hepatitis B virus, human immunodeficiency virus (HIV) or other immunodeficiencies;

13. Participants that have previously been consented to this protocol;

14. Participants with a hypersensitivity to mAb treatments, protein derived from a mAb, or immunoglobulin therapy;

15. Participants with allergies to diphenhydramine, epinephrine, and methylprednisolone;

16. Participants who are direct employees or family members of direct employees of the participating investigators' sites;

17. Participants who are direct employees of the Sponsor;

18. Participants who, in the opinion of the Investigator, are unable to complete cognitive testing due to inadequate visual or auditory acuity.

Related Conditions & MeSH terms

• Alzheimer Disease
• Amnesia
• Cognitive Dysfunction
• Memory Disorders
• Memory Impairment
• Memory Loss
• Mild Cognitive Impairment

Intervention

Other:
• Prescreener database
Identify and characterize participants with reported memory complaints and/or cognitive impairment to determine the probability of randomization into a therapeutic AD clinical trial.

Locations

Country	Name	City	State
Canada	OCT Research	Kelowna	British Colombia
United States	Visionary Investigator's Network	Aventura	Florida
United States	iResearch	Decatur	Georgia
United States	Re:Cognition Health	Fairfax	Virginia
United States	Quest Research Institute	Farmington Hills	Michigan
United States	Charter Research	Lady Lake	Florida
United States	JEM Research Institute	Lake Worth	Florida
United States	ClinCloud, LLC	Maitland	Florida
United States	K2 Medical Research	Maitland	Florida
United States	Merritt Island Medical Research	Merritt Island	Florida
United States	Renstar Medical Research	Ocala	Florida
United States	IPS Research	Oklahoma City	Oklahoma
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Pacific Research Network	San Diego	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	ClinCloud, LLC	Viera	Florida
United States	Premiere Research Institute at Palm Beach Neurology	West Palm Beach	Florida
United States	Charter Research	Winter Park	Florida
United States	Conquest Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Global Alzheimer's Platform Foundation

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (6)

Baek MJ, Kim K, Park YH, Kim S. The Validity and Reliability of the Mini-Mental State Examination-2 for Detecting Mild Cognitive Impairment and Alzheimer's Disease in a Korean Population. PLoS One. 2016 Sep 26;11(9):e0163792. doi: 10.1371/journal.pone.0163792. eCollection 2016. — View Citation

Berry CC. A tutorial on confidence intervals for proportions in diagnostic radiology. AJR Am J Roentgenol. 1990 Mar;154(3):477-80. doi: 10.2214/ajr.154.3.2106207. No abstract available. — View Citation

Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018. — View Citation

Kantarci K. Molecular imaging of Alzheimer disease pathology. AJNR Am J Neuroradiol. 2014 Jun;35(6 Suppl):S12-7. doi: 10.3174/ajnr.A3847. Epub 2014 Feb 6. — View Citation

Niemantsverdriet E, Valckx S, Bjerke M, Engelborghs S. Alzheimer's disease CSF biomarkers: clinical indications and rational use. Acta Neurol Belg. 2017 Sep;117(3):591-602. doi: 10.1007/s13760-017-0816-5. Epub 2017 Jul 27. — View Citation

O'Bryant SE, Humphreys JD, Smith GE, Ivnik RJ, Graff-Radford NR, Petersen RC, Lucas JA. Detecting dementia with the mini-mental state examination in highly educated individuals. Arch Neurol. 2008 Jul;65(7):963-7. doi: 10.1001/archneur.65.7.963. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine number of patients eligible for therapeutic Alzheimer's Disease clinical trial	Participants with reported memory complaints and/or cognitive impairment will provide demographic information, clinical history, complete brief cognitive assessments, and provide blood-based biomarkers	Throughout study completion, an average of 45 days