Safety Study of a Glycogen Synthase Kinase 3 (GSK3) Inhibitor in Patients With Alzheimer´s Disease

NCT00948259 | Completed Phase 1

• 1 other identifier: NP031112-08B03 (CR080901)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate if 4 escalating doses during 20 weeks of NP031112 are safe and tolerated in patients with Alzheimer´s disease.

Conditions

Alzheimer´s Disease

Keywords

safety; GSK inhibitor; Alzheimer

Outcome Measures

Primary Outcomes (1)

• Incidence rates and severity of clinical adverse events and lab abnormalities for each dose level and placebo

  20 weeks

Secondary Outcomes (1)

• Effect of treatment with four doses of NP031112 on cognition and depressive mood

  20 weeks

Study Arms (2)

NP031112

EXPERIMENTAL

Patients will receive 400 mg of NP031112 for 4 weeks, if tolerated, they will receive 600 mg for 4 additional weeks. Patients that tolerate this dose will receive 800 mg for 6 weeks and the patients that tolerate this will escalate to 1000 mg for an additional 6 weeks. Patients that are not eligible for dose escalation will remain on the tolerated dose for the remainder of the study.

Drug: NP031112

Placebo

PLACEBO COMPARATOR

Patients will receive 400 mg for 4 weeks, if tolerated, they will receive 600 mg for 4 additional weeks. Patients that tolerate this will receive 800 mg for 6 weeks and the patients that tolerate this will escalate to 1000 mg for an additional 6 weeks. Patients that are not eligible for escalation will remain on the tolerated dose for the remainder of the study.

Drug: Placebo

Interventions

NP031112 DRUG

unidose sachets containing dry powder for oral suspension, once daily dosing 400 mg (4 to 20 weeks), 600 mg(4 to 16 weeks),800 mg (6 to 12 weeks), 1000 mg (6 weeks)

Also known as: tideglusib, NP12

NP031112

Placebo DRUG

unidose sachets containing dry powder for oral suspension, once daily dosing 400 mg (4 to 20 weeks), 600 mg(4 to 16 weeks),800 mg (6 to 12 weeks), 1000 mg (6 weeks)

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women (non-childbearing potential) with a diagnosis of probable Alzheimer's disease according to the NINCDS-ADRDA clinical criteria.
• Age 60 - 85 years (patients over 85 years could be included after a previous assessment by the investigator and in agreement with the sponsor)

You may not qualify if:

• Mild to moderate stage of Alzheimer's disease according to MMSE 16-26.
• Modified Hachinski ischemic score equal to or below 4.
• Geriatric Depression Scale below or equal 7.
• Female patients must be either surgically sterilized or at least 1 year postmenopausal (confirmed by FSH \>20, for women not surgically sterilized).
• A caregiver/nurse is available and is living in the same household, or interacts with the patient to assure the correct preparation and administration of the study drug to the patient.
• Patients living at home or old people's home.
• General health status acceptable for a participation in a 6 months clinical trial.
• Ability to swallow 100 -150 ml of water suspension.
• No daily-regular/chronic intake of medications acting on central nervous system, immunosuppressants, steroids or non-steroid anti-inflammatory agents except the following allowed treatments:
• SSRIs as antidepressants if they are administered at a stable and well tolerated dose for two months prior to baseline evaluation
• the following drugs at a stable and well tolerated dose to symptomatic treatment of mild behavioral disorder, sleep onset-insomnia or mild depressive mood:
• Risperidon max 1mg/day
• Quetiapin max 25mg/day
• Zolpidem max 10mg in the evening
• Lorazepam max 1mg/day

Sponsors & Collaborators

• Noscira SA: lead

Study Sites (3)

Pharmacologische Studiecentrum Chemnitz

Chemnitz, 09111, Germany

Location

Arzneimittelforschung Leipzig GmbH

Leipzig, 0410Y, Germany

Location

Studienzentrum PD Dr. Steinwachs

Nuremberg, D- 90402, Germany

Location

MeSH Terms

Interventions

tideglusib

Study Officials

• Klaus-Christian Steinwachs, MD

  Studienzentrum PD Dr. Steinwachs

  PRINCIPAL INVESTIGATOR

• Manfred Windisch, Ph.D.

  JSW Life Sciences GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 29, 2009
• Study Start: December 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 11, 2009

Record last verified: 2009-11

Locations

DE (3)