Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment

• Sponsor: AbbVie (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02573740
• Collaborator: (none)
• Enrollment: 8
• Locations: 9
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 0.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose study of ABT-957 in participants with mild Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI) due to AD.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease; Mild Cognitive Impairment	Drug: ABT-957; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate the Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of Multiple Doses of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment Due to Alzheimer's Disease
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-957 ABT-957 given twice a day for 84 days	Drug: ABT-957
Placebo Comparator: Placebo Placebo given twice a day for 84 days	Other: Placebo

Outcome Measures

Primary Outcome Measures

1. Percentage of participants reporting treatment-emergent adverse events [For approximately 84 days]

2. Level of spectrin breakdown product-145 (SBDP-145) [84 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female participants must have negative results for pregnancy test performed on a serum sample obtained at Screening

• Body Mass Index is 18.0 to 35.0 at Screening

• Meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable Alzheimer's disease (AD).

• Meets the NIA-AA core clinical criteria for Mild Cognitive Impairment due to AD

Exclusion Criteria:

• Use of any strong inhibitors of drug metabolizing enzymes within 30 days prior to study drug administration

• Consumption of alcohol within 24 hours prior to study drug administration

• Positive screen for non-prescribed drugs of abuse or alcohol

• The participant has clinically significant abnormal laboratory values at Screening as determined by the investigator

• History of a drug or alcohol abuse within 6 months prior to study drug administration

• Current diagnosis of major depression or other major psychiatric disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 143180	Cypress	California	United States	90630
2	Site Reference ID/Investigator# 143178	Orlando	Florida	United States	32806
3	Site Reference ID/Investigator# 149484	The Villages	Florida	United States	32162
4	Site Reference ID/Investigator# 143181	Marlton	New Jersey	United States	08053
5	Site Reference ID/Investigator# 143182	Cincinnati	Ohio	United States	45255
6	Site Reference ID/Investigator# 149481	Dallas	Texas	United States	75231
7	Site Reference ID/Investigator# 143254	Orem	Utah	United States	84058
8	Site Reference ID/Investigator# 143179	Salt Lake City	Utah	United States	84107
9	Site Reference ID/Investigator# 143177	Spokane	Washington	United States	99202

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Nuno Mendonca, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02573740
• Other Study ID Numbers: M13-730
• First Posted: Oct 12, 2015
• Last Update Posted: Jul 6, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by AbbVie: Mild Cognitive Impairment; Alzheimer's Disease
• Additional relevant MeSH terms: Alzheimer Disease; Cognitive Dysfunction

Study Results

No Results Posted as of Jul 6, 2021