Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease

NCT00948909 | Completed Phase 2

• 2 other identifiers: M10-9842009-011424-64
• Study Type: interventional
• Target: 274
• Locations: 6 countries
• Sites: 29

Brief Summary

This is a efficacy and safety study evaluating new treatment for subjects with mild to moderate Alzheimer's Disease.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion

  Measurements up through 12 weeks.

Secondary Outcomes (1)

• MMSE, QoL-AD, CIBIC-plus, NPI, CSDD, ADAS-Cog (13 item) and ADCS-ADL. Note: Acronyms are fully defined in the area titled Detailed Description.

  Measurements up through 12 weeks.

Study Arms (4)

A. Sugar Pill

PLACEBO COMPARATOR

Drug: Placebo

B. ABT-126

EXPERIMENTAL

Drug: ABT-126

C. ABT-126

EXPERIMENTAL

Drug: ABT-126

D. donepezil

ACTIVE COMPARATOR

Drug: donepezil

Interventions

Placebo DRUG

Placebo intervention

Also known as: Sugar Pill

A. Sugar Pill

ABT-126 DRUG

Experimental intervention

B. ABT-126; C. ABT-126

donepezil DRUG

Active comparator intervention

Also known as: Aricept

D. donepezil

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1.
• The subject meets the NINCDS/ADRDA criteria for probable AD.
• The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1.
• The subject has a Modified Hachinski Ischemic Scale (MHIS) score of less than or equal to 4 at Screening Visit 1.
• If female, subject must be postmenopausal for at least two years or surgically sterile
• The subject has an identified, reliable, caregiver.

You may not qualify if:

• The subject is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1
• The subject has a history of any significant neurologic disease other than AD.
• In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
• The subject has reported history of discontinuation of donepezil due to lack of efficacy.
• The subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation.
• The subject has a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients in either donepezil hydrochloride or ABT-126 formulations.
• Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence.
• Subjects with AST and ALT values at Screening Visit 1 that are greater than or equal to 1.5-fold the upper limit of normal (ULN).

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (29)

Site Reference ID/Investigator# 19904

Fresno, California, 93720, United States

Location

Site Reference ID/Investigator# 23025

West Palm Beach, Florida, 33407, United States

Location

Site Reference ID/Investigator# 19905

Indianapolis, Indiana, 46260, United States

Location

Site Reference ID/Investigator# 22944

Pleven, 5800, Bulgaria

Location

Site Reference ID/Investigator# 22942

Plovdiv, 4000, Bulgaria

Location

Site Reference ID/Investigator# 22945

Sofia, 1113, Bulgaria

Location

Site Reference ID/Investigator# 22946

Sofia, 1431, Bulgaria

Location

Site Reference ID/Investigator# 20276

Litoměřice, 412 01, Czechia

Location

Site Reference ID/Investigator# 20273

Pilsen, 301 36, Czechia

Location

Site Reference ID/Investigator# 20274

Prague, 100 00, Czechia

Location

Site Reference ID/Investigator# 20272

Prague, 120 00, Czechia

Location

Site Reference ID/Investigator# 20701

Prague, 15006, Czechia

Location

Site Reference ID/Investigator# 23625

Bratislava, 82606, Slovakia

Location

Site Reference ID/Investigator# 23624

Bratislava, Slovakia

Location

Site Reference ID/Investigator# 23622

Michalovce, 07101, Slovakia

Location

Site Reference ID/Investigator# 23942

Rimavská Sobota, 979 12, Slovakia

Location

Site Reference ID/Investigator# 20267

Belville, 7530, South Africa

Location

Site Reference ID/Investigator# 20266

Cape Town, 7500, South Africa

Location

Site Reference ID/Investigator# 20261

Durban, 4001, South Africa

Location

Site Reference ID/Investigator# 21682

George, 6529, South Africa

Location

Site Reference ID/Investigator# 20265

Johannesburg, 2196, South Africa

Location

Site Reference ID/Investigator# 20271

Port Elizabeth, 6001, South Africa

Location

Site Reference ID/Investigator# 20263

Richards Bay, 3900, South Africa

Location

Site Reference ID/Investigator# 20187

Blackburn, BB2 3HH, United Kingdom

Location

Site Reference ID/Investigator# 20183

Bradford, BD3 0DQ, United Kingdom

Location

Site Reference ID/Investigator# 20191

Crowborough, TN6 1HB, United Kingdom

Location

Site Reference ID/Investigator# 20184

Glasgow, G20 0XA, United Kingdom

Location

Site Reference ID/Investigator# 20190

London, TW8 8DS, United Kingdom

Location

Site Reference ID/Investigator# 20192

Southampton, SO30 3JB, United Kingdom

Location

Related Publications (1)

• Gault LM, Ritchie CW, Robieson WZ, Pritchett Y, Othman AA, Lenz RA. A phase 2 randomized, controlled trial of the alpha7 agonist ABT-126 in mild-to-moderate Alzheimer's dementia. Alzheimers Dement (N Y). 2015 Jun 23;1(1):81-90. doi: 10.1016/j.trci.2015.06.001. eCollection 2015 Jun.

  PMID: 29854928 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Sugars; ABT-126; Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Laura Gault, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2009
• First Posted: July 29, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

CZ (5); SL (4); BU (4); US (3); ZA (7); GB (6)