A Phase 2, Single Arm, Study of the Biomarker Effects of ALZ-801 in Subjects with Early Alzheimer’s Disease Who Are Carriers of the e4 Variant of the Apolipoprotein E Gene (APOE4/4 or APOE3/4)

Alzheon Inc.0 sites85 target enrollmentJune 8, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Alzheon Inc.
Enrollment: 85
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 8, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Alzheon Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Be between ages of 50 and 80 years, inclusive
•2\. Has a body weight \= 50 kg
•3\. Has a diagnosis of Probable AD Dementia or MCI due to AD in accordance with NIA AA Working Group Criteria
•4\. Has a biomarker profile reflecting AD, accord. to the NIA\-AA Research Framework defined as follows
•a) Positive amyloid PET scan on file prior to Screening OR
•b) CSF AD biomarker result using Lumipulse (Fujirebio) assay at Screening with:
•i. Aß\-42/Aß\-40 ratio \< 0\.61 AND
•ii. p\-tau \> 61 ng/L OR
•iii. if p\-tau181 concentration\=50 to 61ng/L, ratio of p\-tau/Aß\-42 \> 0\.11 OR
•c) CSF AD biomarker result on file within 12 months prior to Screening that is positive for Aß\-42 (below the cut\-off) AND p\-tau (above the cut\-off) OR a p\-tau181/Aß\-42 ratio above the cut\-off for that assay (amyloid AND p\-tau positive)

Exclusion Criteria

•1\.Has a brain MRI at screening indicative of significant abnormality, incl. but not limited to, prior hemorrhage (\> 1 cm) or large infarct (\> 1 cm), \> 2 lacunar infarcts outside the brain stem, severe white matter changes (Fazekas grade 3\), superficial hemosiderosis \> 1 cm, aneurysm, vascular malformation, subdural hematoma, space\-occupying lesion (e.g., abscess or brain tumor such as meningioma), or ventricular enlargement consistent with normal pressure hydrocephalus
•Note: Ventricular enlargement consistent with AD atrophy(hydrocephalus ex\-vacuo) is not exclusionary
•Note: Subjects who have \> 10 microbleeds, require approval by Sponsor Med. Monitor
•2\.Has a diagnosis of neurodegenerative disorder other than AD
•3\.Has a current diagnosis of MDD accord. to criteria of Diagnostic and Statistical Manual of Mental Disorders\-5th Ed. Subjects who do not meet current criteria for MDD and who are on stable doses of antidepressants or mood stabilizers may be included in the study at discretion of Investigator
•4\.Has a history of suicidal behavior or has ongoing suicidal ideation
•5\.Has a history of seizures (excl. febrile seizures of childhood, or a single distant seizure \> 10 years). Subjects with a history of one seizure, but without evidence of vascular or mixed dementia, or brain tumor on MRI, may be allowed into study at discretion of Med. Monitor
•6\.Has a medically confirmed history of recent cerebral infarct or recent transient ischemic attack (within 1 year prior to Scr–Part 2V)
•7\.Has a medically confirmed history of recent myocardial infarction or unstable, untreated coronary artery disease, or angina pectoris (within 1 year prior to Scr–Part 2V)
•8\.Has a history of cancer, diagnosed and treated within last 3 years prior to Scr–Part 2V, with exception of following: (a) treated basal cell carcinoma of the skin; (b) treated in situ or Stage 1 cancers of skin (squamous cell only), colon, prostate, breast, or colon