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Open-Label Treatment With MPC-7869 for Patients With Alzheimer's Who Previously Participated in an MPC-7869 Protocol

M

Myrexis

Status and phase

Terminated
Phase 3

Conditions

Alzheimer's Disease

Treatments

Drug: MPC-7869

Study type

Interventional

Funder types

Industry

Identifiers

NCT00380276
MPC-7869-05-009

Details and patient eligibility

About

Open-label treatment with MPC-7869 for participants in a previous randomized study.

Enrollment

1,000 estimated patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participation in a previous MPC-7869 randomized protocol
  • Have had a diagnosis of probable Alzheimer's disease.
  • Men or women ages 55 years or greater and living in the community at the time of enrollment (i.e., not living in a rest home or nursing care facility).
  • Signed the subject Informed Consent Form and is willing and able to participate for the duration of the study.
  • Female subjects must be surgically sterile or postmenopausal for > 1 year.
  • Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.

Exclusion criteria

  • History or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. Men with prostate cancer may be enrolled at the discretion of the sponsor.
  • Chronic or acute renal, hepatic or metabolic disorder.
  • Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

1,000 participants in 1 patient group

Open Label Arm
Other group
Description:
Treatment is open-label
Treatment:
Drug: MPC-7869

Trial contacts and locations

90

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Data sourced from clinicaltrials.gov

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