NCT03712787

An Extension Study of an Active Drug in Early Alzheimer's Disease (AD)

Brief summary

The purpose of this study is to assess the long-term safety and tolerability of an active drug in subjects with early AD.

Interventional study

Status:
Terminated
Conditions:
Alzheimer's Disease
Enrollment:
364 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-570
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

Would you like to know more about this trial?

alert image Please note, participation in the clinical trial is open to patients with the disease or condition under investigation.
Yes, please contact me

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 57 Years to 88 Years.

Inclusion Criteria:

- All subjects with early AD who complete Study M15-566 (NCT02880956), meet all
inclusion criteria, and do not meet any exclusion criteria are eligible for enrollment

- Subject was compliant during participation in Study M15-566 (NCT02880956)

- Subject has an identified, reliable study partner who has frequent contact with the
subject and who will provide information as to the subject's cognitive and functional
abilities

Exclusion Criteria:

- The subject has any significant change in his/her medical condition since
participation in Study M15-566 (NCT02880956) that could interfere with the subject's
participation in Study M15-570, could place the subject at increased risk, or could
confound interpretation of study results

- More than 8 weeks have elapsed since the subject received his/her last dose of study
drug in Study M15-566 (NCT02880956)

- The subject is concurrently enrolled in another interventional clinical study
involving a therapeutic agent with the exception of Study M15-566 (NCT02880956)

All the cities where the clinical studies are located

London - N6C 0A7
Toronto - M3B 2S7