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Alzheimer's Disease Long-term Follow-up Study (ALF Study)

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Eisai

Status and phase

Completed
Phase 4

Conditions

Alzheimer's Disease

Treatments

Drug: Donepezil Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00165724
EKI-1002

Details and patient eligibility

About

Open study for efficacy and safety of donepezil treatment during 48 weeks

Enrollment

114 patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • Men or women aged 40 to 90
  • Diagnosis of dementia according to DSM-IV
  • Diagnosis of probable AD as defined by NINCDS-ADRDA criteria
  • Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26
  • Patients were generally healthy and ambulatory or ambulatory aided
  • Patients did not take acetylcholinesterase inhibitor 4 weeks before screening
  • Patients have useful MRI results 3 months before screening

Exclusion

  • If they have evidence of TIA or major infarction
  • Epilepsy patients
  • If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse
  • If they sensitive to acetylcholinesterase
  • If they taken concomitant medication which were not allowed

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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