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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01661673

NCT01661673
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • Part 1 (Healthy Volunteers): Men and women between 45 and 65 years old who are in good general health, have a body weight in the normal-to-moderate range (BMI 18–32), and test negative for drugs of abuse in a urine test.
  • Part 2 (Memory/Cognitive Concerns): Men and women between 45 and 85 years old who have had brain scans (MRI or CT) suggesting mild cognitive impairment (MCI) or early Alzheimer's disease, and who meet specific medical guidelines for MCI related to Alzheimer's.
  • Part 2 (continued): Participants must have a BMI of 18–32, report memory concerns, show mild thinking or memory difficulties in one or more areas, score within a certain range on standard memory and thinking tests (CDR-SB score of 1.0 or lower and MMSE score above 24), and still be able to function normally in daily social and work life.

Who may not be able to join:

  • People with a history of seizures, episodes of dizziness when standing up, certain abnormal heart rhythm readings (QTc above 450 ms), or a positive test for drugs of abuse.
  • Women who are pregnant, breastfeeding, or who are able to become pregnant but are not willing to use birth control during the study.
  • People who have had recent thoughts of suicide at a serious level (scoring 4 or 5 on a standard suicide risk questionnaire).
  • People who are not willing to avoid intense or vigorous exercise during the study.
  • People who have another medical condition (separate from MCI or early Alzheimer's) that is causing their memory or thinking problems.
  • People whose lower spine X-rays show a physical reason why a lumbar puncture (spinal tap) cannot be safely performed.
  • People with a history of spinal surgery or long-term lower back pain.
  • People with a history of migraine headaches.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
FORUM Pharmaceuticals Inc
Registry
clinicaltrials_gov
Start date
1 November 2012
Est. completion
1 October 2013

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The number of adverse experiences reported by subjects and/or observed by investigator and repeated clinical evaluations of physical examinations, vital signs, 12-lead ECG (electrocardiogram), and lab tests (hematology, chemistry, urinalysis); To measure the rate of synthesis of Amyloid Beta in cerebral spinal fluid of healthy subjects; To measure the concentration of Amyloid Beta in cerebral spinal fluid

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov